Novartis jobs in Durham, NC

Manage Quality aspects of clinical programs and projects within area of responsibility. Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems. Identify and execute on OpEx opportunities. Build/manage stakeholder relationships and expectations Job Description Location: Durham, NC #LI-Onsite Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Major accountabilities: Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. Contributes to an improvement of current processes and/or to an implementation of modified processes. Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: In accordance with departmental objectives such as support of projects with agreed quality and delivery date -passing of internal and external inspections. Maintain sound working relationships with partners and customers -Demonstrated/recognized leader of specific GxP; early external/industry engagement -Basic financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values & behaviors for his/her department Minimum Requirements: Work Experience: Functional Breadth. Collaborating across boundaries. Operations Management and Execution. Project Management. Skills: Agility. Audit Management. Business Partnering. Change Control. Continuous Learning. Health Authorities. Influencing Skills. Knowledge Of Capa. Qa (Quality Assurance). Quality Management. Quality Management Systems (Qms). Risk Management. Root Cause Analysis (Rca). Self Awareness. Sop (Standard Operating Procedure). Technological Expertise. Languages : English. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77,000 and $143,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $77,000.00 - $143,000.00 Skills Desired Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Role: The Global Study Associate is a member of the global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours. Typical Accountabilities: Support GS(A) D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently. Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs. Provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes. Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents. Contribute to electronic applications/submissions in regulatory information management system by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR. Initiate, maintain and/or support the creation of study documents, ensuring template and version compliance per study specific requirements. Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools. Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs. Support the GS(A) D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems, including the creation and maintenance of purchase orders, running invoice and payment reports. Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out. Coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs. Lead the coordination and contribute to the preparation of internal and external meetings e.g., study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors. Prepare, contribute and distribute presentation material for meetings, newsletters and websites. Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager. Other duties as assigned and within scope of role. Essential Experience: Bachelor level education, with at least 2 years' experience in in medical or biological sciences or discipline associated with clinical research preferred Proven study admin/assistant or relevant experience on a study level with experience in clinical study lifecycle Proven organizational and analytical skills Previous administrative training/experience Computer proficiency in day-to-day tasks Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines Excellent verbal and written communication in English Demonstrate ability to work independently, as well as in a team environment Ability to prepare presentation materials Demonstrate professionalism and mutual respect Willingness and ability to train others on study administration procedures Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing *********************************. #LI-Hybrid Date Posted 15-Dec-2025 Closing Date 01-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** Member of a team that is collectively responsible for operating/monitoring a chemical manufacturing process that produces bulk organic chemicals. This position requires an individual who will abide by Company standards and operating procedures in order to maintain a safe operation while producing in-specification product. Standard tasks include: packaging product, taking process samples, changing filters, cleaning centrifuges, moving large hoppers, flushing lines, etc. He/she will also be responsible for accurately filling out operating reports and documentation. This position works on a 12hr rotating shift schedule. The schedule uses a four-week cycle: four night shifts, three days off, three day shifts, one day off, three night shifts, three days off, four day shifts, seven days off. **Job Description** **ESSENTIAL FUNCTIONS:** + Operates in a regulated environment and complies with all PSM and OSHA regulations applicable to manufacturing responsibilities. This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities + Operates and monitors reactors, decanters, filters, process columns, tanks, centrifuges, dryers, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens + Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices + Maintains detailed operating reports and logs, including notes on problems, weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor + Delivers samples to laboratory and retrieves operating supplies from storeroom + Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. + Operates hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points + Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations. + Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. + Complete computer based training on time + Other duties as assigned by Management **MINIMUM REQUIREMENTS:** _Education:_ High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. _Experience:_ Previous PSM manufacturing experience preferred _Skills/Competencies:_ Forklift Operation preferred. _Other Skills:_ Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats. Must be able to perform basic math. Possess sound decision making skills. Must work in a team environment to cover work stations during breaks and lunches Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly. + Performs Lock Out/Tag Out (LOTO) independently. + Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity **RELATIONSHIP WITH OTHERS/ SCOPE:** + Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. + No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. **WORKING CONDITIONS:** + The plants open-air construction exposes operators to the normal year-round outside climate. However, all "homebase" workstations are indoors. + Typical chemical plant environment. Wet floors are common, chemical staining of equipment makes environment appear "dirty", and chemical fumes are occasionally present in the work areas. + Must handle average to heavy weight materials (50lbs) by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury. + Must be able to physically climb stairs/ladders, roll drums, lift and pour bags of raw materials, drive forklifts and perform first aid. + Large quantities of corrosive, flammable, and toxic materials are present in the plant. Layers of protection are in place to maintain a safe work environment, but the presence of these materials/chemicals is inherently hazardous. + Must be able to work rotating 12 hours/day shift and overtime as needed. + Mandatory overtime is necessary to keep plant staffed to safe levels. The mandatory overtime is handed out to the shift on "long-off" (7-Day Break). + May be required to wear a full-face respirator contingent upon required job duties. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Specialist, Global Clinical Solutions As part of Global Medicines Development (GMD), Clinical Operations is accountable for delivering clinical studies. Global Clinical Solutions (GCS) enables this mission by providing industry-leading processes, technology, and centralized services that help Clinical Operations and its partners deliver development programs to time, cost, and quality. The GCS Specialist supports high-quality, complete operational data, robust lifecycle management of systems and processes, and effective training and adoption across user communities. We are recruiting IRT Leads to oversee our Interactive Response Technology (IRT)/ Randomization & Trial Supply Managment (RTSM) systems that manage randomization, drug supply, and site/subject activities for clinical studies. In this role, you will support study teams through the full lifecycle-set-up, maintenance, and close-out-of the IRT system tailored to each clinical protocol. You will drive vendor management, ensuring performance, quality, compliance, and timely delivery across IRT providers. Successful candidate requires emerging project management skills-we expect you to bring at least one (e.g., planning, risk/issue tracking, or stakeholder communication) and show strong willingness to learn and develop the others. Impact: This role safeguards data integrity and regulatory readiness, streamlines operational processes and tools to accelerate study delivery, and strengthens user capability and adoption across Clinical Operations. Key responsibilities: Service delivery across drug projects: ensure consistent, complete, and high‑quality Clinical Operations data; partner with Study Teams and external vendors. Systems and tools enablement: set up, maintain, validate, and test Clinical Operations systems/tools; manage lifecycle, business continuity, standards, and procedural/system documentation. Training and user enablement: deliver process/system/tool trainings; facilitate knowledge sharing; establish best practices and support effective communication within Clinical Operations. Process excellence and improvement: analyze usage to identify efficiency and effectiveness opportunities; contribute to user requirements and UAT; support business cases for continuous improvement. Change participation: contribute to change initiatives related to Clinical Operations. Essential qualifications: Bachelor's degree and 2+ years of experience. Strong organizational and analytical skills; proven multitasking and time management. Computer proficiency; excellent spoken and written English; strong communication skills. Demonstrated alignment with AZ Values and Behaviours. Prior administrative training/experience. Desirable qualifications: Degree in biological sciences or a healthcare-related field. Understanding of clinical study processes and pharmaceutical development; knowledge of regulations (ICH GCP); GxP training. Experience in pharma or clinical development environments. Ability to train others on study support processes and proactively identify risks/issues and solutions. The annual base pay for this position ranges from $77,236.80 - $115,855.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 19-Dec-2025 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Aggregate, clean, and standardize historical and new delivered dose uniformity (DDU) data, define metadata and data models, and help establish workflows for automated data ingestion and validation. Collaborate with analytical scientists and automation engineers to map test parameters, instrument outputs, and quality controls into a robust, searchable database. Development of simple dashboards or reports, and data integrity checks to enable reproducible analyses and regulatory-ready traceability. Position Requirements: Junior students majoring in engineering, chemistry, data science, or a related field Coding skills such as Python or SQL. Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design. Proficiency in MS Office 365. Candidates must have an expected graduation date after August 2026. US Work Authorization is required at time of application. This role will not be granting CPT support. Ability to report onsite to Durham, NC 5 days per week. This role will not provide relocation assistance. Compensation range: $37-39 per hour Date Posted 16-Dec-2025 Closing Date 08-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** Summary 12 Hour Rotating Shift (7am - 7pm & 7pm -7am) SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. + Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. + Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. + Performs repairs and modifications as directed by maintenance supervisor, or other plant management. + Supports and participates in training programs. + Keeps the maintenance supervisor abreast of job status. + Supports site safety programs. + Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. + Accurately completes all required paperwork, including but not limited to timesheets, "found as-left" forms, calibration reports (ICIR), and PM checklists. + Responsible for good housekeeping in the shop and at the job site. + Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Other duties as assigned with or without accommodations. + Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. + Accurately enters all required information on work orders. + Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. + Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. _Experience:_ 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. _Preferred Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy **RELATIONSHIP WITH OTHERS/ SCOPE:** + Reports to Maintenance Supervisor. + Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. + No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. + Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. + Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. **WORKING CONDITIONS:** + I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. + Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. + Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. + Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. + May be required to wear a full-face respirator contingent upon required job duties. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. **** Job Description **ESSENTIAL FUNCTIONS** **:** + Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. + Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. + Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. + Performs repairs and modifications as directed by maintenance supervisor, or other plant management. + Supports and participates in training programs. + Keeps the maintenance supervisor abreast of job status. + Supports site safety programs. + Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. + Accurately completes all required paperwork, including but not limited to timesheets, "found as-left" forms, calibration reports (ICIR), and PM checklists. + Responsible for good housekeeping in the shop and at the job site. + Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** Other duties as assigned with or without accommodations. + Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. + Accurately enters all required information on work orders. + Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. + Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. _Experience:_ 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. _Preferred Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy **RELATIONSHIP WITH OTHERS/ SCOPE:** + Reports to Maintenance Supervisor. + Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. + No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. + Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. + Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.WORKING CONDITIONS:I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. + Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. + Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. + Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

The Sr. AD, Regional Sales - Rheumatology is responsible for the overall Rheumatology Sales Team within the assigned geography in the US focusing on Rheumatologists. This includes the development of the regional level business plan and implementation of the BIPI sales/marketing plan to assure optimal market penetration of BIPI and co-promoted products within BIPI guidelines, policies and directives. The Sr. AD has a very high working knowledge of markets across the region, commercial key accounts, public and private payers and national account influences. She/he will continuously maximize the use of key company resources and budgets to exceed sales targets and appropriately position Boehringer Ingelheim within the Rheumatology market. The Sr. AD also ensures equal and consistent application of established policies and procedures in the management of employees to meet or exceed sales goals. 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 an opportunity for all employees to collaborate internationally, offering visibility and the 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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Recruits, leads, and coaches a team of 7-10 territory sales consultants, to ensure that regional sales performance meets or exceeds annual company sales and market share objectives. + Collaborates closely with Marketing, Managed Markets, Reimbursement and Access, Associate Director of Patient and Community Clinical, Trade Operations, and other ILD stakeholders to coordinate regional area resources to maximize sales. + Manages region to a level of productivity while allocating resources appropriately and within budget. + Identifies, recruits, and develops high performing talent. + Defines clear actionable objectives, allocates resources, provides development opportunities, and conducts ongoing performance reviews continuously. + Encourages direct reports to own their career development and take full advantage of the company's career development offerings. + Drives high performance management of all personnel in the region including all disciplinary action to ensure personnel are meeting expectations in their roles. + Spends appropriate amount of time cultivating and maintaining highly productive relationships with relevant ILD customers, networks, and stakeholders to understand customer needs and anticipate shifts in market conditions. + Anticipates and quickly responds to the needs of the customer in a timely and professional manner. + Exhibits a high level of expertise in effectively utilizing HUB services to address customer needs. + Develops and maintains productive, mutually beneficial business relationships with key accounts in all classes of trade. + Actively initiates and contributes to the development of the National marketing and long-term strategic plans. + Utilizes appropriate data sources to develop actionable regional business plan at a leading level. + Leads the development of the regional business plans to ensure alignment with marketing, stakeholders, and organizational goals. + Attends and participates in management and marketing meetings to represent field needs and help to develop product strategies and resources to ensure that the sales force has the support needed to increase our market penetration. + Adheres to policies and implements sales strategies. + Initiates discussions to provide honest and open feedback to senior management on the effectiveness and results of policies, strategies, and procedures within the region. + Executes a process for implementation and quarterly measurement of the regional business plans. + Monitors payer environment and has in-depth understanding of the processes and mechanisms for influencing ILD treatment guidelines through Local, Regional and National pathway companies. + Anticipates how payers integrate pathways into treatment guidelines and develop actionable regional plans which will maximize product penetration. + Initiates managed care planning process with stakeholders in proactive way to ensure access. **Requirements** + Bachelor's degree required; MBA degree preferred. + Minimum of seven-plus (7+) years successful pharmaceutical sales experience, including three-plus (3+) years leading a sales team in specialty required. + Track record of building high performing teams and working in a cross functional matrix environment. + Requires at least one (1) year prior experience demonstrating acct. management, leveraging HUB services, collaborating with PaCE & specialty pharmacies, supporting reimbursement navigation, working individually outside a "pod" structure, fostering market development, regional Key External Expert (KEE) engagement & relationship management, linking KEEs with appropriate internal stakeholders, fluency in the inner networking & navigation of teaching institutions. + Excellent communications, objective setting, and influencing skills. + Ability to travel - including overnight travel (inclusive of some weekend programs), approximately 10- 50%, depending on geography. + Valid Driver's License and acceptable driving record. + Proficiency in PowerPoint, Excel, Word, Outlook, and data base application. + In depth understanding and proven experience in driving commercial success in the ILD/Pulmonary market is a plus; Success operating within a matrix environment where direct reports and their constituents are interdependent on others' engagement with customer universe. **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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Shift Production Supervisor is responsible for supervising PAP Chemical Operators while directing the manufacturing operation in the PAP plant. The Shift Supervisor is responsible for documentation for accurate record keeping and troubleshooting. Job Description ESSENTIAL FUNCTIONS: Directs the Chemical Operators to achieve goals as directed by the PAP Plant Manager. Strictly enforces expectations as it pertains to personal protective equipment requirements for all activities performed in the PAP Plant by Chemical Operators, Maintenance Personnel, Contractors, etc. Writes Safe Work Permits and performs Lock Out/Tag Out (LOTO). This includes Hot Work permits and Confined Space Entry Permits. Oversees the work of Chemical Operators and ensures all work is performed in accordance with company policy and procedure especially safety and regulatory requirements. Ensures Chemical Operators, Maintenance Personnel, and Contractors keep PAP Plant clean, neat, and ordered. Coordinates training and conducts performance appraisals of Chemical Operators. Manages work schedule for Chemical Operators to ensure proper staffing and safe operations Maintains complete and accurate production records, reviews and approves operating reports, time reports, incidents reports (EHS Suites entries), attendance reports, and personnel documents. Manages PAP manufacturing operation. Oversees troubleshooting and monitors the manufacturing process. Manages process problems and coordinates necessary equipment repairs with Maintenance Planner. Serves as an emergency brigade leader for the Plant site in the event of an emergency. Must be able to wear the required Personal Protective Equipment (PPE), such as full-face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel-toe shoes, gloves, chemical-resistant smocks and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Communicates current plant status to oncoming shift to ensure smooth transition Escalates high impact events to PAP Plant Manager in a timely manner Maintains good personnel relations and discipline to help maintain high employee morale in a non-union workforce. Implements programs for continual development and training of Chemical Operators through formal programs and personal involvement. Serves as a Subject Matter Expert. Ensures that Chemical Operators are equipped with the necessary and proper tools to perform their work. Finalizes lot production through label accounting and recording Reports production variations as well as shift overall performance to the PAP Plant Manager. Provides Process Engineers with accurate information about process status. Must occasionally physically assist the Chemical Operators in problem situations. These activities require moderate levels of physical stress such as climbing stairs and ladders, inspecting equipment and wearing safety equipment. May serves as a member of various employee involvement teams and committees, such as Lean/Six Sigma, Hazmat and/or Cost Savings, to improve the workplace, increase efficiency, and improve productivity. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. Experience: 10-15 years experience in a chemical manufacturing environment. 5 years of supervisory experience preferred. Must have a thorough understanding of chemical plant equipment and its proper operation. Requires knowledge of company policies and a tactful approach to implementation. Familiarity with federal and local regulations is fundamental with regards to labor relations, plant emission control and hazardous waste handling. Requires a conceptual view of support groups and their interaction with plant personnel. Must possess a working knowledge of principles of supervision. Preferred Skills/Qualifications: Other Skills/Competencies: Must be able to effectively communicate in both verbal and written formats. Must be able to multi-task. Sound decision making skills. Must be able to perform basic math. Strong computer skills (MS Office and E-mail). Action Oriented, Informing, Problem Solving, Team Approach Learning on the Fly, Conflict Management, and Documentation RELATIONSHIP WITH OTHERS/ SCOPE: Directly responsible for supervising Chemical Operators. This supervision entails all aspects of plant functions as performed by the Operators, most of which is fairly standardized. Has direct control over Operator's work load and job location in plant. Reviews performance and trains Chemical Operators in technical aspects of plant operation and monitors their performance. Job performance is reviewed by the PAP Plant Manager to ensure implementation of Company policies in attaining goals. Works closely with Process Engineers to ensure optimum plant productivity. Successful completion of duties has a direct impact on the level of plant efficiency. Advises the PAP Plant Manager and Process Engineers on current process status, as well as being instrumental in making recommendations for optimization of equipment operation and personnel utilization. Internal contacts are made on a daily basis with first line management in areas such as: Maintenance, EHS, and Quality Assurance. Although external contact is uncommon, occasional interaction with corporate support groups or outside contractors is necessary to coordinate work being done in the plant. WORKING CONDITIONS: The plant's open-air construction exposes operators to the normal year-round outside climate. Some relief from the elements is available in the control rooms and break area. Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used, when possible, but use of proper lifting and movement techniques is necessary to prevent injury. Must be able to physically negotiate stairs and evacuation ladders, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts. Must be able to work rotating 12 hours/day shift and occasional overtime as needed. May be required to wear a full-face respirator contingent upon required job duties. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: OH, WV, VA, NC, SC, KY, TN. Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working. Accountabilities: In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes. Essential Skills/Experience: University degree at Bachelor level, in a scientific or business discipline 5-10 years of project/portfolio/resource management, in a Clinical Development environment Broad drug development experience in a matrix environment Minimum 5 years of working experience and understanding of business planning and capacity management process Ability to look for and champion more efficient and effective methods/processes Goal oriented and ability to drive performance Experience in converting organizational needs into demand algorithms Experience in developing demand algorithms for Clinical Development Strong data modelling skills and the ability to transform data into forms easily understood by others The ability to balance tact, patience and persistence with the need to move improvements at speed Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms Desirable Skills/Experience: Advanced degree Business relationship management skills Accredited/Certified in Project Management tools/systems Proven ability with enterprise project management systems When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives. Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare! Date Posted 15-Dec-2025 Closing Date 30-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Job Title: Director, Technology Alliance Management (Alliance Lead) Introduction to the role: Be part of a dedicated Research & Development team. Fueled by our commitment to help more patients, strengthen our pipeline and grow our area. This is the place to go beyond discovery - we think holistically about patients and are always learning from those living with diseases. The Alliance Management (AM) group sits within BioPharma Clinical Operations and is accountable for setting the sourcing strategy across R&D and managing adherence to it. They ensure our suppliers deliver to the needs of the organizations and develop strong, beneficial partnerships with key suppliers. About the role: The role of the Alliance Management Director is to act as the Alliance Lead for one or more supplier(s). They will be responsible for ensuring the supplier(s) are meeting the operational needs of the customers; ensuring alliance effectiveness, appropriate communications, ensuring that selected partners deliver to contract; and that strong relationships with the external suppliers are created and maintained. This role will support and lead Patient Recruitment and Retention. Accountabilities: Supplier / Model Governance Accountable for the alliance management of one or more supplier(s) within or across service line(s) Proactively identifies and manages risks at the supplier/model/service line level Serves as point of contact for issue escalation to AM for their assigned supplier (s), and key in ensuring solutions are identified in collaboration with the business stakeholders. Facilitates resolution of any operational issues that impact delivery Leads operational governance of the supplier(s)/ service line(s) In collaboration with the AM Group Lead, contributes to executive level governance meetings; and contributes to or leads model level governance and supplier council forums, as Acts as audit Sponsor and/or audit co-ordinator for AZ led supplier audits as applicable Supplier / Model Quality and Performance With the AM Group Lead ensures definition of appropriate Metrics and SLAs for the supplier within the MSA Monitors quality and performance of service deliverables in alignment with the MSA Ensures that selected suppliers deliver to contract and that strong relationships with the external suppliers and internal customers are created and maintained Ensures effective visibility of supplier performance to relevant stakeholders Ensures ongoing assessment and integration of Lessons Learned for suppliers / models/service lines Seeks opportunities to drive efficiencies and continuous improvement within supplier and model/service lines Study Team Support Ensures understanding of roles and responsibilities across delivery teams for assigned delivery model(s) / service line(s) Works with AM Process Integration Lead, internal subject matter experts and counterparts in supplier organizations to ensure the effective use and maintenance of interface processes / ways of working (e.g. Alliance Handbooks) Alliance Management Development May have responsibility for line management or coaching of junior members of the team Serves as a delegate for the AM Group Lead for specific tasks or activities, as necessary May support or lead key critical initiatives within AM and contribute to initiatives outside of AM Essential Requirements University degree in related field, or equivalent (Phd/MSc preferred, BSc required with 10+ yrs of experience within the pharmaceutical industry or clinical research organization Strong experience from within the pharmaceutical industry or clinical research organization Detailed knowledge of clinical and pharmaceutical drug development process at various phases of development Experience of working successfully with external partners / managing relationships Experience of directing alliance governance frameworks and processes (incl performance metrics) Strong leadership and influencing skills, especially without authority Strong collaboration skills across global and functional boundaries Excellent conflict resolution, mediation and negotiation skills Ability to work with agility to solve problems that involve many decision makers, and develop multiple options/recommendations Familiar with ICH GCP and related guidelines and practices Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Make a more meaningful impact to patients' lives around the globe! Apply today! Date Posted 15-Dec-2025 Closing Date 06-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. Innovation & Execution Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. Thought Leadership & External Engagement Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. Team Leadership & Development Manage and mentor a diverse team of data scientists and people managers across geographies. Foster career growth through open dialogue, performance management, and strategic development planning. Operational Excellence Ensure GxP compliance in data science programming for clinical trials. Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. Executive Communication Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications Ph.D. in Biostatistics, Bioinformatics, or related computational sciences. Deep expertise in statistical methods and their application in clinical trials. Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people leadership experience in a Data Science setting. Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

The Manager, Technical Compliance, is responsible to support the DI Lead at Gene Therapies North Carolina Site on the Data Integrity Program and support the quality risk management program, including creation, implementation, defining, monitoring and reporting KPIs, creating solutions for KPI improvement and continuous improvement of the program. In addition, the Manager is responsible for the maintenance and monitoring of Quality Engineering and QA IT. The manager will also be responsible for being the Data Integrity Deputy for the GTxNC site. About the Role Location: This position will be located in Durham, NC and will be able to work on Hybrid schedule Key Responsibilities * Manages a team that oversees quality engineering and QA IT. * Manages the team to ensure on time delivery of compliance activities related to QA IT and Quality Engineering. * Manages the staff responsible for the regulatory CMC related launches and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements * Supporting the Maintenance and Monitoring of the Quality Risk Management Program * Assists the DI Lead with proactively drives establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program. * Serves as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools. * Identifies and maintains a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.). * Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture. * Drives continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc. * Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties. * Facilitates the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.). * Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk. * Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy. * Responsible for supporting QA approval of quality management records for the QA quality systems team. Essential Requirements: * BSc in Chemistry, Biology, Pharmacy, business, or related experience. * Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred. * 10 years' experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries. Experience in advanced therapies (CGT, RLT, etc) is preferred. * Experience with of industry Data Integrity related experience. Prior experience with aseptic manufacturing is preferred. * Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, preclinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred. * Knowledge of applicable cGMP regulations, for example, FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, * EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills. * Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations. * Experience working in a diverse, fast-paced, local and global SME matrix environment, with ability to drive and manage change. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $201,500 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Hybrid Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities: Oversees URS, protocols, reports & support records to ensure compliance, timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities). Performs environmental mapping and other miscellaneous validation activities. Evaluates and analyzes validation data for accuracy and adequacy. Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment. Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries. Owns validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports. Reviews and supports Computer Systems Validation efforts for global systems. Manages workload to ensure timely approval of validation testing and documentation. Assists Quality Assurance, Production, Quality Control and other departments during inspections or audits. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Other related duties as assigned. Requirements: BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred).. Experience with Biosafety cabinet smoke studies. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Experience supporting FDA approved, commercial products. Experience in cGMP environment (IQ, OQ, PQ) is essential. Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects. Experience with validation tools and processes, including environmental mapping and use of Kaye Validator. Familiar with GAMP 5 applications and practices. Excellent technical writing and verbal communication skills. Proficient in Microsoft Word, Excel, PowerPoint, and Project. Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution. Skills: Business Continuity. Change Control. Flexibility. General Hse Knowledge. Hvac (Heating Ventilation And Air Conditioning). Including Gdp. Installations (Computer Programs). Knowledge Of Capa. Knowledge Of Gmp. Manufacturing (Production). Project Commissioning. Project Engineering. Project Execution. Risk Management. Root Cause Analysis (Rca). Languages: English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $89,600.00 - $166,400.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

Manager, Global Clinical Solutions (GCS) / IRT Lead Enable efficient delivery of GCS services and technology for clinical programs. Lead Interactive Response Technology (IRT)/Randomization & Trial Supply Management (RTSM) systems across study lifecycle - set-up, maintenance, and close-our - covering randomization, drug supply, and site/subject activities. Drive continuous improvement and ensure delivery to time, cost, and quality. We are recruiting IRT Leads to oversee our Interactive Response Technology (IRT)/ Randomization & Trial Supply Managment (RTSM) systems that manage randomization, drug supply, and site/subject activities for clinical studies. In this role, you will support study teams through the full lifecycle - set-up, maintenance, and close-out - of the IRT system tailored to each clinical protocol. You will drive vendor management, ensuring performance, quality, compliance, and timely delivery across IRT providers. Successful candidate requires strong project management skills, including planning, risk/issue management, stakeholder communication, and on-time execution. Key responsibilities Service delivery and lifecycle management of GCS processes, systems, and tools; ensure business continuity and compliance. IRT/RTSM leadership: translate protocol requirements into system design, oversee configuration, UAT, go‑live, maintenance, and decommissioning. Vendor management: manage IRT providers for scope, quality, compliance, timelines, and SLAs; resolve issues and ensure on‑time delivery. Project management: plan and track milestones, manage risks/issues and changes, communicate clearly with stakeholders, and report progress. Training and user enablement: deliver training on processes/systems/tools, facilitate knowledge sharing, define best practices, and maintain communications across GCS and AZ. Process improvement: analyze usage and performance, identify efficiency opportunities, build business cases, and lead Lean‑driven improvements. Performance monitoring and change delivery: monitor KPIs, implement operational changes, embed continuous improvement and effective knowledge management. Essential qualifications Bachelors degree in life sciences/healthcare and 4+ years of experience. Strong project management, analytical and organizational skills; stakeholder management and presentation skills. Excellent written and spoken English. Proven risk and issue management; effective use of escalation and governance. Ability to build relationships and achieve outcomes without direct line authority; curious, self‑motivated, and proactive. Desirable Expertise in GCS/IRT services; experience with Lean Six Sigma and Quality Management Systems (QMS). ≈2+ years in drug development or clinical operations; understanding of ICH GCP. Experience in a complex, global organization and cross‑functional collaboration. The annual base pay for this position ranges from $98,893.60 - $148,340.40. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 19-Dec-2025 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** We are seeking a skilled and safety-focused welder to join our team. The ideal candidate will have proven experience in pipe and plate welding along with metal fabrication. S/he has ability to interpret blueprints, project plans, and isometric drawings to complete pipe fitting and welding tasks. S/he must be able to accurately pre-fab and install pipe replacements and upgrades. This role requires strong technical knowledge, attention to detail, and the ability to collaborate with construction and maintenance teams to ensure safe, high-quality project execution. **Job Description** + **Blueprint and Drawing creation and interpretation** + Create, read, and interpret project plans, blueprints, piping diagrams, and isometric drawings. + Translate written instructions and diagrams into precise fabrication and installation tasks. + **Fabrication and Installation** + Measure, cut, thread, groove, bend, and weld pipes according to specifications. + Prefabricate piping systems and confirm alignment, tolerances, and fit prior to installation. + Assemble pipes, fittings, and valves using appropriate tools, equipment, and joining techniques. + Understanding and experience with carbon steel, stainless steel (304L & 316L), aluminum, and alloy 20 metals, among others. + Ensure accurate pipe fit-up and compatibility with structural components. + Repair equipment in the field, as needed, including within confined spaces. + **Testing and Quality Control** + Inspect and test completed piping systems for leaks, durability, and compliance with industry standards. + Identify issues, perform adjustments, and report malfunctions or defects to supervisors. + Ensure adherence to project specifications, codes, and safety regulations. + **Collaboration and Teamwork** + Work closely with welders, fabricators, and construction crews to ensure seamless project integration. + Participate in failure analysis and troubleshooting to address causes of equipment or system failures. + Communicate effectively with supervisors, engineers, and team members. + **Safety and Compliance** + Support and follow all site safety programs, policies, and guidelines. + Wear and maintain all required Personal Protective Equipment (PPE), including full-face respirators, hard hats, safety glasses, gloves, steel-toe boots, and chemical-resistant gear when necessary. + Contribute to a safe work environment by practicing proper housekeeping in the shop and on job sites. + **Equipment and Maintenance** + Operate and maintain pipefitting machinery and tools (cutting torches, threading machines, grinders, calipers, etc.). + Ensure equipment is used safely and kept in good working condition. + Report any equipment malfunctions promptly. **Requirements** + Minimum of 2 years' proven experience as a Pipe Fitter. + Strong ability to read and work from blueprints, isometric drawings, and piping diagrams. + Skilled in pipe fabrication, alignment, and installation processes. + Familiarity with welding processes and ability to collaborate with welders during fit-up and installation. + Proficiency in using tools and equipment such as cutters, threading machines, torches, squares, and calipers. + Ability to pass fit-up or pipefitting assessments as required. + Strong attention to detail with a results-driven and safety-focused approach. + Physical ability to stand, bend, squat, and lift heavy materials regularly. + Must be able to work in varying environmental conditions (indoor/outdoor, hot/cold, confined spaces). + Commitment to workplace safety and compliance with all PPE requirements. **Preferred Qualifications** + Experience working on industrial, commercial, or construction piping systems. + Knowledge of relevant codes and standards (ASME, ANSI, OSHA, etc.). + Ability to weld pipe and plate using GTAW and SMAW methods when required. + Demonstrated teamwork and communication skills in a construction or industrial setting. + Ability to perform basic NDE techniques, such as visual examination and liquid dye penetrant examination. **Work Environment** This position involves work in both shop and field settings. Candidates must be able to adapt to changing work environments, including exposure to noise, dust, extreme temperatures, and confined spaces. Pipe Fitters must also be able to work at heights and in physically demanding conditions while maintaining strict adherence to safety standards. Shop and industrial manufacturing areas without climate control. Must be able to go up and down several flights of steps on occasion. **DISCLAIMER:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.