Novo Nordisk jobs in Durham, NC

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position The purpose of the position is to operate utility and RMS process equipment to support API-US production. Responsibilities include operation of applicable equipment within the scope of the department. Other duties will be receiving materials, completing training and supporting quality & financial goals for the site. Establish & maintain positive working relationships with internal & external stakeholders and ensure all activities are aligned with Environmental Health & Safety (EHS) program expectations. Relationships Reports to Manager. Essential Functions Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems Identify and document system or operational anomalies for cause & clearance to minimize downtime and ensure a safe working environment Maintain standards & operational procedures for automated and manually operated systems Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety) Support stakeholders as required for successful plant operations including maintenance and optimization activities Execute raw material movement and offload into process systems Execute site rounds and equipment inspections independently to ensure efficient and compliant operations Adhere to all Quality & Environmental regulations Participate in systematic problem-solving efforts Manage individual training plan Perform routine cleaning and good housekeeping as needed for assigned areas Review electronic batch records real-time to ensure compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications High school graduate or GED required Bachelor's Degree in a relevant field of study from an accredited university preferred BioWork certification or equivalent a plus Minimum of 6 months of related experience in regulated industry required Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) a plus Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred Basic knowledge of production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems preferred Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade preferred Ability to read/review equipment documents with a basic understanding preferred Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts a plus Computer literacy with associated systems required Proven ability to check results & revise work tasks to meet daily plan preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The Director, GxP Training Lead, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the organization. The position provides strategic oversight for training governance, program design, and operational excellence, enabling the organization to meet inspection readiness and continuous improvement goals. **Key Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. + Establish governance frameworks for training compliance, including policies, SOPs, and audit readiness. + Serve as the primary training authority during regulatory inspections and internal audits. **Program Development & Delivery** + Design and oversee GxP training programs for all regulated functions (e.g., R&D, Manufacturing, Clinical, Quality). + Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH). **Compliance & Risk Management** + Monitor training compliance metrics and proactively address gaps to mitigate regulatory risk. + Maintain audit-ready documentation and ensure adherence to GxP standards across global operations. **Stakeholder Engagement & Collaboration** + Partner with functional leaders, Quality Systems, and HR to align training initiatives with business priorities. + Act as a trusted advisor to senior leadership on training compliance trends, risks, and mitigation strategies. **Continuous Improvement & Analytics** + Define KPIs and leverage data analytics to measure training effectiveness and drive enhancements. + Stay current with regulatory changes, industry best practices, and emerging technologies to evolve training programs. **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 10+ years in pharmaceutical or life sciences industry with significant experience in GxP compliance and training leadership. + Proven track record in designing and implementing global training programs and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Hospital / Institutional Customer Representative is a key member of the Hospital Customer Team and plays a critical role in supporting our Company's customer centric business model. He/she is responsible for working with the Hospital Customer Team to understand and identify Health Care Provider (HCP) customer needs, support pull-through activities relative to the customer strategy and ensure that our Company is viewed as demonstrating value and better health outcomes to healthcare professionals and their patients. **The primary activities include:** + Communicates about product in a way that's meaningful and relevant to each individual customer; customizes discussions and client interactions based on understanding of customer's needs + Engages in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Within select customer accounts acts as primary point of contact for customer, meet with key customers/personnel to understand practice structure, business model, key influencers Managed Care Organization (MCO), employers, state and local regulations)/network structure, customer needs and identifies business opportunities + For select customer accounts/HCPs, coordinate with customer team to develop customer strategy - outlining strategy for interactions/ relationship, solutions and potential offerings for customer + Partners with National Account Executives (NAEs) to maintain strong focus on Managed Care pull-through + Shares learning and best-practices from one customer to help other customers meet their needs + Demonstrates a focus on better health outcomes (beyond acquisition, considers the HCP and patient experience) + Provides input into resource allocation decisions across customers + Identifies and selects programs/services available in the library of our Company's "resources" to address customer needs + Works with solutions group (Headquarters - HQ) and/or Medical Account Executive (MAE) to develop and deliver relevant offerings that address desired customer needs + Maintain current understanding of practice structure, business model, key influencers/ network structure and make information available to relevant stakeholders + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our Company's divisions and functional areas; ensure integration with National Account Executive (NAE), our Company's Vaccines personnel, Health Management Services (HMS) Manager, Solutions Consultant, Customer Strategies and Solutions (CSS), Regional Medical Director (RMD) and other key stakeholders to share key customer learning and support customer needs + Outstanding in all competency areas (Account Management; External Market Focus; 1:1 Customer Interactions) + Influences beyond their specific geography or product area + Implements approved resources, programs and messages to address customer and company needs. + Create awareness of approved Inpatient Hospital Letters of Participation (LOP) with eligible and appropriate customers. To include discussing approved details of the contract. **Territory Information:** + This is a field-based sales role responsible for covering the Fort Lauderdale, FL territory, including but not limited to Coral Springs, Delray Beach and Aventura. + This territory may also include surrounding towns, suburbs, and other nearby communities + Travel (%) depends on the needs of the territory and where the selected candidate resides. **Qualifications** **Education Minimum Requirements:** + Bachelor's Degree with 3 (36 months) or more years Sales experience **OR** a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices). **Required:** + Prior experience working in a scientific field or healthcare environment + Previous sales experience + Prior experience developing new business opportunities with existing customers + Experience establishing new customer relationships + Understanding of our Company's products and therapeutic areas + Consistent performer in most competency areas + Valid Driver's license **Preferred:** + Prior consulting or customer service experience + Experience developing and executing a plan for engaging customers and meeting customer needs + Understanding of Headquarter operations + Ability to analyze metrics to assess progress against objectives + Hospital/Institutional Sales experience **Required Skills:** Accountability, Accountability, Account Management, Account Planning, Adaptability, Business Management, Business Model Development, Business Opportunities, Client Communication, Customer Contact Management, Customer Experience Design, Customer Experience Management, Customer Feedback Management, Customer Rapport, Customer Strategy, Digital Analytics, Health Outcomes, Hospital Sales, Interpersonal Relationships, Lead Generation, Market Analysis, Pharmaceutical Sales Training, Resource Allocation, Sales Calls, Sales Metrics {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $104,200.00 - $163,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** n/a **Job Posting End Date:** 12/17/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R375495

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Boehringer Ingelheim is currently seeking a talented and innovative Pharmaceutical Sales Intern to join our diabetes sales team in one of our nine national regions. You will work with a team of experienced sales professionals who will guide you through a real world, hands-on experience in selling pharmaceuticals. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Duties & Responsibilities Participate and successfully complete training and selling skills development. In partnership with a mentor/coach, engage with customers and participate in clinical discussions (including virtual engagements). Attend weekly conference calls with regional field sales team to capture learnings and gain valuable insights. Schedule appointments for sales colleagues and participate in in-service programs. Requirements Must be a current undergraduate student in good academic standing; December 2026 and May 2027 graduates only. Must be enrolled at a college or university for the duration of the internship. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred Must have completed at least 12 credit hours at current college or university. Must have reliable transportation and valid driver's license. Must be able to work the full duration of the internship (May 18, 2026 - August 14, 2026). Desired Experience, Skills & Abilities: Strong interpersonal skills Digital proficiency Ability to analyze qualitative and quantitative information Demonstrated ability to work in a team environment Ability to execute and follow through on priorities Eligibility Requirements: Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older

The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site. Position Responsibilities: Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program Function as a change agent related to culture and audit program performance Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities Achieve and maintain auditor qualification status through robust training and continuing education Lead training/orientation for new Quality Auditing staff Ensure preparation of annual audit schedule, using risk-based approaches Schedule and perform assigned audits for site program. Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations. Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites Review, and approve Audit Reports Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program Review and ensure CAPA responses to Audits and Inspections are robust Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards Lead company and site preparation activities for support of regulatory and customer inspections Provide compliance advice to site, development and commercial product teams Supports and continually enhance the ongoing site Permanent Inspection Readiness status Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics Education Minimum Requirement: Bachelor's degree in engineering, Biology, Chemistry or related field Required Experience and Skills: Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements Knowledge of Quality Systems within a GMP environment Demonstrated ability to establish and maintain collaborative relationships with key stakeholders Ability to work independently with limited supervision Ability to build relationships and influence across disciplines and all levels Preferred Experience and Skills: GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred) Experience with leading effective audits and obtaining meaningful audit observations “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas, based on site activities; Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product Specific technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation) Knowledge of QBD development & submission requirements, as applicable to site Ability to lead, motivate, develop and mentor other auditors Knowledge of and experience in Quality Risk Management methods Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable Experience with hosting or participating in Health Authority inspections and/or Divisional audits Highly motivated, flexible, and have excellent organizational and communication skills Excellent verbal and written communication skills Ability to prioritize and balance work from multiple projects in parallel Required Skills: Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 12/24/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each day. **About the Role** The Omnichannel Center of Excellence is dedicated to driving innovation, building, and delivering capabilities that enhance Otsuka's opportunity to make an impact in the lives of those we serve. We achieve this through our relentless focus on customer centricity, patient empathy, expertise in enabling pathways for disease education and awareness of management options, and our unwavering commitment to supporting access to treatment. We are looking for an **Omnichannel Data Scientist** , **Medical Omnichannel** with strong expertise in artificial intelligence, encompassing machine learning, data mining, and information retrieval. This position specifically entails the conceptualization, prototyping and development of next generation advanced analytics model-based decision engines and services. The ideal candidate will engage closely with key stakeholders to understand strategic objectives and leverage advanced data analytics and machine learning techniques to enhance communication strategies, ensuring seamless and personalized interactions with healthcare professionals (HCPs) and key opinion leaders (KOLs). **Job Expectations/Responsibilities:** **Data Integration & Management** + Explore and analyze common pharmaceuticals data (e.g., claims) as well as novel data sets based on lab and EHR systems. Work with Omnichannel Data Engineer to Integrate data from multiple sources (e.g., CRM systems, social media, email platforms) to create a unified view of stakeholder interactions. + Apply natural language processing (NLP) to extract insights from unstructured medical texts, such as clinical notes or call center transcripts. + Identifying relevant data drivers (features) that can inform decision making closely tied with strategy and creating visualizations to help communicate findings. **Advanced Analytics & Modeling** + Implement advanced analytics models, including predictive analytics and clustering algorithms, to generate actionable insights and track trends across various channels. + Work with Omnichannel ML/Ops engineer to build, test, and deploy production-grade predictive models and algorithms as part of the Omnichannel COE decision engine to meet business needs, including optimization of sales activities and predicting drivers of customer behavior. + Create repeatable, interpretable, dynamic, and scalable models that are seamlessly incorporated into analytic data products and match the needs of Otsuka's growing portfolio. + Collaborate on MLOPS life cycle experience with MLOPS workflows traceability and versioning of datasets. Build and maintain familiarity with Otsuka Machine Learning tech stack including AWS, Kubernetes, Snowflake, and Dataiku **Omnichannel Optimization** + Design and deploy recommendation systems to tailor communications based on stakeholder preferences and behaviors. Utilize machine learning algorithms (e.g., collaborative filtering, content-based filtering) to enhance personalization efforts. + Analyze the performance of omnichannel campaigns (email, SMS, in-app, HCP portals, etc.) to identify high-impact touchpoints and optimize engagement strategies. Use A/B testing and uplift modeling to evaluate the effectiveness of different communication strategies and content types. **Stakeholder Collaboration** + Effectively communicating analytical approach to address strategic objectives to business partners. + Work closely with medical affairs, marketing, and IT teams to ensure alignment and integration of omnichannel strategies. Provide technical guidance and support to cross-functional teams on data-related projects. + Stay updated with emerging industrial trends (Conferences and community engagement) and develop strategic industry partnerships on Omnichannel analytics to strengthen Otsuka's analytical methods and outcomes. + Model Otsuka's core competencies (Accountability for Results, Strategic Thinking & Problem Solving, Patient & Customer Centricity, Impact Communications, Respectful Collaboration & Empowered Development) that define how we work together at Otsuka. Key matrixed partners included: Brand Marketing, Creative / CRM / Digital agencies, Media, Market Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/Regulatory/Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree in data sciences, computer science and 4-6 years of relevant experience **Preferred Knowledge, Skills, and Abilities:** + Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus, etc.) is a plus. + Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred. + Excellent interpersonal, technical, and communication skills to lead cross-functional teams. + Profound grasp of Machine Learning lifecycle - feature engineering, training, validation, scaling, deployment, scoring, monitoring, and feedback loop. + Have implemented machine learning projects from initiation through completion with particular focus on automated deployment and ensuring optimized performance. + Agile skills and experience + Experience in Healthcare (esp. US) industry is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Support proper implementation & execution of maintenance activities for API production equipment & systems within DAPI-US facility. Improve the reliability & performance of API operations tracks with respect to equipment/systems maintenance. Utilize a reliability centered mindset to maximize plant productivity, while maintaining equipment performance & longevity. Primary tasks include: Lead & coordinate maintenance performance improvement projects & initiatives, Support manufacturing & production support teams to ensure maintenance compliance, Provide technical support to the site & stakeholders to meet business goals and Coach & mentor members of the maintenance team. Relationships Reports to Senior Manager, Maintenance Support. Essential Functions Write/review maintenance plans, specifications & SOPs Participate in equipment/system design reviews & support equipment installation, commissioning & qualifications Assist in maintaining quality & schedule within area of responsibility Establish & maintain positive working relationship with internal & external engineering & operations stakeholders Lead & provide technical support for investigation, troubleshooting & problem resolution of equipment & system operational issues Support development, implementation & improvement of equipment & systems maintenance plans during operation Continuous improvement: verify process equipment & satisfy design requirements/expectations Knowledge sharing with local & DK facilities Develop knowledge of risk assessment documents, such as requirements risk assessments (RRA's) Support the review & updating of engineering & specification documentation (process flow diagrams, P&IDs, user req specifications, etc.) Drive maintenance team adherence to PSM requirements & best practices Participate in the review & updating of process & system risk assessments Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid drivers license. Qualifications Bachelor's Degree in engineering (preferred degree in maintenance, mechanical, chemical, electrical, bio-process engineering), or equivalent industrial, military, or vocational training combined with experience required Minimum three (3) years of experience working directly in utilities or process equipment maintenance, or other directly related field required Demonstrated experience in plant operations & maintenance with proven knowledge in RCA, troubleshooting, problem resolution & continuous improvement preferred Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment a plus Six Sigma Green Belt certification or cLEAN 2-star desired a plus Demonstrated experience in maintenance processes & mechanical systems preferred Practical knowledge in the following areas: mechanical systems operations, root cause analysis (RCA), reliability centered maintenance (RCM), process hazard assessment (PHA), process safety management (PSM) & process improvement methodologies (Six Sigma, Lean Sigma) a plus Technical/process/functional knowledge of utility systems components maintenance & operation including cooling & chilled water, plant steam (HP & LP), compressed air, clean steam & purified water preferred Technical/process/functional knowledge of specific equipment maintenance & operation including but not limited to pumps (centrifugal, PD, diaphragm, mag drive, other), heat exchangers, control valves, mixers, agitators & filtration preferred Technical/process/functional knowledge of API systems components maintenance & operation to include centrifugation, spray drying & chromatography a plus Experience with using records control systems (SAP, CMMS or similar system) a plus Ability to read & understand equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings & other specialized documentation required Knowledge & understanding of technical documents such as URS, SAT, FAT, qualification & validation protocols a plus Experience using controls & control interfaces for PLC, PCS, BMS & DCS systems a plus Ability to independently apply engineering techniques & analysis within the discipline preferred Strong project management skills a plus Excellent oral & written communication skills preferred Proven expertise in developing/planning/coordinating maintenance activities & following up on results preferred Experienced in creating &/or revising work plans for complex problems being resolved by cross functional teams a plus We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: * Leading pay and annual performance bonus for all positions * All employees enjoy generous paid time off including 14 paid holidays * Health Insurance, Dental Insurance, Vision Insurance - effective day one * Guaranteed 8% 401K contribution plus individual company match option * Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave * Free access to Novo Nordisk-marketed pharmaceutical products * Tuition Assistance * Life & Disability Insurance * Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to Manager, Technical Support. Essential Functions * Coach & mentor peers, Engineering personnel & Process Maintenance Technicians. * Support technical development of Process Maintenance Technicians & Technical Area Specialists. * Employ advanced cLEAN tools within the main areas of problem solving, project & change management. * Lead cross-functional process improvements. * Develop plans to improve the performance of a process or set of systems, using green belt concepts. * Develop & manage project budget for improvements for a process or set of systems. * Support event response activities. * Support implementation of better practices & participate in sharing knowledge across all OFP sites for improvement projects. * Maintain & establish standards for procedures & maintenance plans. * Support global OFP collaboration initiatives. * Additional accountabilities, as required. Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications * Bachelor's Degree in engineering/related field or an equivalent combination of experience & education required. * Minimum of five (5) years of engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification or equivalent preferred. * Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), & Reliability Centered Maintenance (RCM) preferred. * Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams preferred. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering positions to partner with Manufacturing Operations, Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our Company's live virus vaccines at Durham. Position Description: We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within out Company's Manufacturing Division, supporting a sterile fill, finish, lyophilization vaccine manufacturing facility in Durham, NC. This state of the art facility, started in 2004, is manufacturing our Company's lifesaving vaccines. Due to the importance of this facility in our Company's Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees over the last several years. The IPT (Integrated Process Team) Support Specialist will be part of a cross functional team charged with the technical support of the manufacturing shop floor in a fill-finish vaccine facility. This role requires the ability to execute multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement. Primary Responsibilities Supporting the Cap and Inspect equipment area by analyzing complex processing problems through critical analytical thinking and “on the floor” troubleshooting Development of sound scientific justification for planned material and process and equipment changes Working with the Operations, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory agency inspections Supporting all quality and safety initiatives Provide technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures Support on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes. Serve as a technical writer for Quality Notifications Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified equipment components Position Qualifications: Education Minimum Requirements Bachelor's degree in an Engineering or Science Related field Required Experience and Skills Minimum two (2) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or military Strategic and effective communication, leadership and teamwork skills Preferred Experience and Skills Optimizing and troubleshooting aseptic processing operations such as formulation, filling, lyophilization, or automated inspection processes Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time. Required Skills: Accountability, Accountability, Adaptability, Change Control Management, Collaborative Communications, Corrective Action Management, Data Analysis, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Hardware Implementation, Healthcare Innovation, Leadership, Lean Manufacturing, Multi-Management, Personal Initiative, Process Automations, Process Optimization, Process Simulation, Professional Integrity, Project Management, Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Operations, Risk Assessments {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 12/25/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world. What we offer you: * Leading pay and annual performance bonus for all positions * All employees enjoy generous paid time off including 14 paid holidays * Health Insurance, Dental Insurance, Vision Insurance - effective day one * Guaranteed 8% 401K contribution plus individual company match option * Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave * Free access to Novo Nordisk-marketed pharmaceutical products * Tuition Assistance * Life & Disability Insurance * Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. This position may be filled at a higher level commensurate with education and/or experience. The Position Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Senior Process Professional and as a mentor/coach for junior team members. Relationships Reports to Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for lower-level team members. Essential Functions * Responsible for providing in depth deviation investigations and root cause analysis * Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications * Responsible for area content and process knowledge * Identify and implement process needs and improvement opportunities for moderate to high complexity issues * Responsible for periodic reviews and reporting. Involved with collaboration across sites * Update and manage area master data and recipes as needed * Provide support on defined issues and contributes through application of expertise and knowledge * Follow all safety & environmental requirements in the performance of duties * Other duties as assigned Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time. (% can change on a case by case basis based on the role.) Qualifications * Bachelor's degree (engineering, technology or related field of study preferred) from an accredited university required * May consider an Associate's degree (engineering, technology or related field of study preferred ) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment * May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment * Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment * Excellent written communication skills required * Thorough investigation and systematic problem-solving experience required * LEAN manufacturing experience and training required * General knowledge of change control systems and Quality Management Systems (QMS) required * Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.) * Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred * General experience with regulatory audits/inspections required * Knowledge of relevant master data preferred * Validation experience preferred * Product transfer (or tech transfer) experience a plus We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

As a Chronic Care Specialty Sales Representative, you will drive meaningful patient impact by leveraging our scientific expertise and serving as the primary contact for customers within your assigned territory. As a key member of the local Customer Team, you will collaborate closely with Account Executives, Integrated Delivery Systems leaders, and other field colleagues to deliver seamless, patient-focused solutions. **Territory Assignment:** This is a field-based sales role responsible for covering a specific territory. Travel (%) depends on the needs of the territory and where the selected candidate resides, and overnight travel may be required about 25% of the time to support client meetings and ensure comprehensive territory coverage. **Position Overview:** In this role, you will develop and manage relationships with a diverse range of specialty health care customers including cardiologists and other approved specialty physicians, physician assistants, nurse practitioners, nurses, pharmacists, and office managers. You will regularly engage with various health care settings such as physicians' offices, integrated delivery systems, pharmacies, and hospital clinics to effectively execute your responsibilities. **Key Responsibilities:** + Develop and execute a territory-level business plan in alignment with company policies, standards, and ethics. + Maintain current product knowledge and certifications for the company's portfolio. + Conduct balanced and compliant product sales discussions with health care providers and business professionals to align customer needs with company products according to product labeling. + Provide management with regular updates on customer needs, marketplace dynamics, and progress toward quality goals. + Be knowledgeable on headquarter approved information regarding approved company products, disease, and marketplace + Monitor business performance against objectives using company tools to support effective planning and sales impact. **Qualifications:** This position's band level will be evaluated based on candidate's qualifications. **Minimum Requirements:** + S1 Level: Bachelor's degree (BA/BS), or High school diploma or equivalent with 0-3 years of relevant work experience, which may include professional sales, marketing, military service, or roles within healthcare or scientific fields such as pharmaceuticals, biotechnology, or medical devices. + S2 Level: Bachelor's degree (BA/BS), or High school diploma or equivalentwith 3+ years Sales experience or a minimum of high school diploma with at least 6 years of relevant work experience whichmay include professional sales, marketing, military service, or roles within healthcare or scientific fields such as pharmaceuticals, biotechnology, or medical devices. + Able to analyze complex data and leverage insights to develop strategic sales plans. + Comfortable using digital tools and platforms to engage with healthcare professionals. + Flexible and adaptable to changing market conditions and customer expectations. + Proven track record of success in both educational and professional environments, demonstrating strong interpersonal, analytical, and communication skills. + Works well both independently, with excellent organizational and time management skills, and collaboratively within team-oriented settings. + Valid driver's license. + Demonstrate strong ability at building and maintaining customer relationships by understanding and addressing their needs effectively. + Reside in the territory or within 25 miles of the workload center for designated metro territories, or within 75 miles for non‑metro territories; if outside these distances, candidates must be willing to relocate at their own expense. **Preferred Experience and Skills:** + Background in sales, account management, consultative roles, or customer service. + Experience analyzing metrics to evaluate progress toward goals. + Minimum of 3 years of relevant sales experience. + Cardiovascular sales experience with established relationships with cardiologists and endocrinologists. + Experience launching products and succeeding in competitive markets. + Ability to simplify complex information and convey technical details clearly. + Proficient in using advanced analytics to generate customer insights and drive sales. + Comfortable leveraging multi-channel tools and technology to expand sales reach and impact. + Demonstrates a proactive learning approach and an agile growth mindset. The salary range for this role is: S1: $77,700.00 - $122,300.00 S2: $104,200.00 - $163,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. CCSales2025 #MSJR **Required Skills:** Account Management, Customer Needs Assessments, Customer Relationship Management (CRM), Health Economics, Interpersonal Relationships, Lead Generation, Market Analysis, Product Knowledge, Sales Forecasting, Sales Metrics, Sales Pipeline Management, Sales Reporting, Sales Strategy Development, Sales Training, Self Motivation **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $77,700.00 - $122,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** n/a **Job Posting End Date:** 12/11/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R375510

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Assist in the operation, maintenance & system management of process control systems. Assist in managing the uptime & availability of the process control systems throughout the site & various facilities. Relationships Reports to Manager. Essential Functions Support troubleshooting during process downtime and plans to maintain & improve process control systems Inspect, troubleshoot & repair control system hardware Perform routine, preventative & predictive maintenance Assist in the development of maintenance procedures Support control system equipment installations and technical clarifications with suppliers & internal stakeholders Assist in managing control system hardware inventory Own self-development & self-initiative to understand the site process control systems Adhere to automation/IT standards and maintain training readiness Utilize the appropriate cLEAN tools when relevant to solve problems or improve processes Manage assignments within compliance with a Quality Mindset that focuses on risk management & mitigation Follow all current Good Manufacturing Practices(CGMPs) & ensures that product is manufactured according to procedure Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications Associate's Degree in Electronics, Computers, Engineering, or a relevant field of study from an accredited university required Minimum of one (1) year of automated/process control system experience required Knowledgeable in supporting & maintaining process control systems preferred Knowledgeable in using Microsoft Office (specifically Outlook, Excel, Word & PowerPoint) preferred Knowledgeable at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred Knowledgeable in the following: PLC (Rockwell, Siemens), HMI, PCS/DCS (DeltaV, iFix ), Historian (OSI PI, iBatch ), SCADA systems, MES (Syncade, PAS-X ), MS SQL preferred Able to troubleshoot PLCs, process control, &/or distributed control systems at an entry level preferred Basic understanding of process control systems for Pharmaceutical, Biotech, Food, Cosmetic, Beverage or relevant work preferred Excellent organizational & planning skills including being familiar with project management methodology preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: * Leading pay and annual performance bonus for all positions * All employees enjoy generous paid time off including 14 paid holidays * Health Insurance, Dental Insurance, Vision Insurance - effective day one * Guaranteed 8% 401K contribution plus individual company match option * Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave * Free access to Novo Nordisk-marketed pharmaceutical products * Tuition Assistance * Life & Disability Insurance * Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Provide routine support & troubleshooting for the batch & documentation review process in production operations. Ensure that batch documentation as well as SOPs & other standardized documentation from production is maintained in accordance with internal & external requirements. Follow-up on and trouble-shoot challenges/ clarifications needed to ensure high-quality batch review. Participate in the continuous improvement of the batch review system to support production plans. Meet or exceed customer, business & regulatory requirements in accordance with Novo Nordisk Way. Relationships Reports to Senior Manager. Essential Functions * Participate in the continuously improve of Purification, Recovery & Fermentation supporting documentation processes * Execute batch review & documentation processes in operations * Support Annual Process Review (APR) documentation & SOP reviews * Ensure real time review to include BPR, logbooks, etc. * Ensure site compliance with cGMPs, ISO standards corporate & local SOPs * Review & approve, in a timely manner, executed batch production records (BPRs) ensuring accurateness & compliance with approved procedures & regulations * Generate ideas for improvement within area & support implementation of ideas * Ability to work in a team for batch reviews * Support minor deviations * Follow all safety & environmental requirements in the performance of duties * Other accountabilities as assigned Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.) Qualifications * Associate's Degree in Technology, Life Science, Pharma or a relevant field of study from an accredited university required * May consider a High School Diploma or equivalent with five (5) years of experience operating in a GMP regulated environment required * Bachelor's Degree Technology, Life Science, Pharma or a relevant field of study from an accredited university preferred * Minimum one (1) year of experience operating in a GMP regulated environment required * Minimum two (2) years of word processing & electronic document distribution required * Experience with documentation in the pharmaceutical industry, like batch reports, SOPs, etc. required * Demonstrated knowledge of requirements/expectations of regulatory authorities e.g. FDA required * Experience with IT systems, e.g. Adobe, Excel, SAP, material control systems, etc. required * Proficient with problem solving techniques required * Demonstrated experience using strong attention to detail, proofreading & strong computer skills with a willingness to learn new IT systems required * Excellent written & oral communication skills required * Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Perform all aspects of truck & bulk liquid unloading to support all operations at API-US facility, including Raw Materials & Solvents, Utilities, Purification, Fermentation, Recovery & Warehouse operations. As part of a high performing work team, ensure bulk liquid (including solvents & raw materials) is delivered into API-US systems throughout the tank farm, utility belt & production receiving areas. Additionally, perform duties in SAP/ERP Inventory Control, including material put-away. Relationships Reports to Manager, RMS & Utilities Operations. Essential Functions Loading & unloading product from trucks, tankers & ISO Containers Operating pumps & valves; blending & mixing chemicals & products as needed during offloads Handling, labelling & storage of hazardous & non-hazardous materials Process material handling operations for hazardous materials in drum, pallet & IBC configurations Ensure all material movements are performed timely & accurately in SAP/ERP Visual & PH inspection on rainwater prior to pumping out containment areas on an as needed basis Perform weekly PH probe calibrations utilizing MES/DeltaV Replace solvent & boundary filters, based on planned maintenance schedules maintained in SAP Partner with warehouse sampling operations in completion of tasks as appropriate Daily inspections of the equipment used in offloading chemicals & materials Adhering to all plant health, safety & environmental guidelines, policies & procedures Keeping work area clean throughout shift Maintain up to date training status Work in a safe & environmentally responsible manner Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications High School diploma/GED, required AS degree in related field, or equivalent industrial, military, or vocational training to include a thorough understanding of mechanical, electrical & control systems, desired HAZWOPER certification &/or relevant training, desired Minimum of two (2) year of truck/bulk liquid unloading or warehousing or equivalent, preferably in a Regulatory Inspected Facility, GMP warehouse or pharmaceutical industry, required Basic math skills, including knowledge of metric system, required Computer competencies required, including basic Microsoft knowledge: Outlook & Word, preferred Knowledge of SAP/ERP to include entry level Warehouse tasks, desired Good written & verbal communication skills, required Ability to read, write legibly & understand all department documentation, required Training or experience demonstrating an understanding of risks inherent to processing, handling & storage of hazardous materials, preferred Ability to operate stand-up & sit-down forklifts after applicable training & maintain appropriate licensure, preferred Ability to drive non-CDL box truck or similar vehicle for movement of materials on site, required Ability to navigate & operate MES & Delta V operating systems, preferred Good organizational skills, preferred Ability to execute a work plan & adapt to changes in schedule rapidly, preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products. + Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges. + Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product). + Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance. + Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests. + Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. + Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc. + Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP. + Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements. + Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met. + Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety. **Qualifications** Required + Bachelor's degree in Chemistry, Biology or other Physical Sciences. + Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial product and development project activities. + Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects. + Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes. + Expertise in conducting root cause investigations and driving CAPA implementation. + Ability to supervise multiple direct reports and projects in a fast-paced environment. + Demonstrated success in working on and leading cross functional teams. + Experience with Pre Approval Inspections for NDAs and BLAs. + Experience in driving continuous improvement projects. + TrackWise Experience. + Excellent interpersonal and communication skills. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Advanced degree in Biology or other Physical Sciences. + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs. This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream, downstream, and/or culture media/support systems. Off-shift and weekend coverage will be required based on business unit needs and specific assignments. Responsibilities may include but are not limited to: Maximum of travel 25% of the time, as needed. Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions. Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with site commercialization efforts Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related) Authoring deviation investigations Collaborate with internal/external partners, e.g. Our Company sites, Procurement, Raw Material & Component Suppliers Develop effective data analytics methodologies, including statistical process control, deepening process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements Provide shop floor hypercare supporting during manufacturing Provide post approval support and subject matter expertise support to ongoing manufacturing activities. Education Minimum Requirement: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree. Required Experience and Skills: Experience in vaccine or biologics manufacturing within a cGMP environment Experience authoring technical documentation within a cGMP context Proven leader with influence and outstanding communication (written & presentation) skills Experience with project strategic plan development and management Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development Preferred Experience and Skills: Experience in manufacturing support processes including weigh and dispense, media/buffer, and sterile supply Experience with single-use component qualification Experience with technology transfer methodologies for introduction/launch of a cGMP product Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions Authored complex process change control Authored complex deviation investigations Experience with validation documentation and execution Experience with SAP Experience with Manufacturing Execution Systems (MES) Experience with Delta V Ability to provide scientific mentorship and guidance to technical colleagues Ability to read Piping and Instrumentation Diagrams Lean Six Sigma belt certification Experience with process risk assessment tools Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA) Experience with face-to-face presentation of technically complex subjects to regulatory inspectors Required Skills: Adaptability, Adaptability, Biodesign, Change Control Management, Chemical Engineering, Collaborative Communications, Continuous Process Improvement, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Support, Personal Initiative, Process Innovation, Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment, Root Cause Analysis (RCA), Strategic Procurement, Technical Writing, Technology Transfer, Vaccine Manufacturing {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 12/25/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

As the Director of Global Marketing (Nephrology & Immunology), you will transform science into strategy by driving global brand strategy, influencing launch preparations and execution, and forging connections across the enterprise **. This role is responsible for the launch of a first-in-class monoclonal antibody within the Nephrology & Immunology portfolio** . A successful candidate must be a strong matrix leader, good communicator and well-rounded global commercial leader, with proven results in shaping and implementing brand strategy, creating and delivering impactful and innovative Global programs to excel performance across the Globe. Clear strategic thinking with the ability to lead and demonstrate passion for the brand is required. You'll join an empowered, fast-paced, high-visibility team at the forefront of scientific innovation, where your work will shape decisions that impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + **Global Launch Leadership & Market Preparation:** Lead cross-functional global launch planning, ensuring alignment across R&D, medical affairs, market access, and regional teams. Drive pre-launch excellence by preparing priority markets with tailored strategies, tools, and stakeholder engagement plans. Develop and execute global launch readiness frameworks, including asset-specific launch excellence scorecards and KPIs. Ability to manage a significant scope of responsibility including multiple indication launch plans and new assets. + **Global Congress & KOL Strategy:** Design and implement a global congress strategy that elevates scientific presence and brand visibility. Build and execute a global KOL engagement plan to cultivate advocacy, shape perception, and inform strategy. Partner with medical affairs to align scientific narratives and ensure consistent messaging across touchpoints. + **Strategic Asset Development & Lifecycle Planning:** Influence target product profiles and indication prioritization with a sharp eye on market differentiation and commercial viability. Co-chair the product development committee with R&D. Shape lifecycle strategies that maximize long-term value, from pre-launch through post-market expansion. Inform the annual Global Asset Planning Process and present to senior leadership. + **Cross-Functional & Regional Collaboration:** Serve as the strategic integrator across global and regional teams, ensuring seamless execution and shared accountability. Facilitate enterprise-wide alignment through structured planning processes and transparent communication. Lead Launch Readiness Reviews with regions as well as Global Brand Team meeting with regions around the globe. + **Budget & Resource Stewardship:** Own global marketing budgets for assigned assets, ensuring strategic investment and ROI-driven execution. **Qualifications** + 10+ years in pharmaceutical or biotech marketing, with deep experience in launch strategy and pre-launch planning, global preferred + Proven success leading cross-functional teams through late-stage development and global commercialization + Expertise in global congress planning, KOL strategy, and market readiness frameworks. + Strong strategic thinking, business case development, and stakeholder influence. + Experience in Nephrology, Immunology, or autoimmune therapeutic areas preferred. + Undergraduate degree in marketing, science, or business required; advanced degree (MBA, PharmD, PhD, MD) strongly preferred. + Location: Remote, with ability to be in Princeton, NJ for moments that matter + Willingness to travel up to 30% globally. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.