Amneal Pharmaceuticals jobs in Piscataway, NJ

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. Perform and verify daily verification data for accuracy and completeness before submitting it for review. Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. Train new peers in LIMS operations, including sample manager and resource modules. Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: Performs other functions as required or assigned. Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. Must understand and apply cGMP requirements applicable to quality control laboratory. Follow up on sample status and testing progress within the LIMS system. Participate in continuous improvement initiatives to optimize LIMS functionality and workflows. Education: Associate Degree - Required Bachelors Degree (BA/BS) Chemistry or related field - Preferred Experience: 1 year or more in Pharmaceutical/manutfacturing Skills: Proficient in laboratory informatics - Intermediate Strong understanding of regulatory compliance (FDA, GMP). - Intermediate Proficiency in inventory management systems and data analysis tools. - Intermediate Excellent organizational, communication, and problem-solving skills. - Intermediate The hourly rate for this position ranges from $22.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Business Support **Job Sub** **Function:** Administration & Secretarial **Job Category:** Business Enablement/Support **All Job Posting Locations:** New Brunswick, New Jersey, United States of America **Job Description:** **We are searching for the best talent for a Global Health Equity Executive Assistant / Coordinator to support the Vice President, Global Head of Social Impact & Partnerships in New Brunswick, NJ.** _Per our J&J Flex Policy, the expectation for this position is to work in the office 3-4 days per week and work from home 1-2 days per week._ **Role Summary** The Executive Administrative Assistant provides high-level administrative and operational support to the Vice President, Global Head of Social Impact & Partnerships. This role is pivotal in ensuring seamless coordination of meetings, projects, and communications, while fostering a positive and efficient team environment. **Key Responsibilities:** **Administrative Support** + Coordinate complex and highly fluid calendars, including scheduling meetings with internal and external partners. + Ensure daily, weekly, monthly, and quarterly priorities are met through effective calendar management. + Partner with internal teams to create and distribute pre-reads and training materials; participate in meetings and manage action items. + Prepare confidential documents, memos, correspondence, and expense reports. + Arrange domestic and international travel logistics. + Support leadership and team meetings by scheduling, preparing agendas and pre-reads, and taking notes. + Manage statements of work and purchase orders using systems such as ARIBA and eMarketplace; track expenditures, develop periodic reports, liaise with vendors, and assist with budget tracking and accruals. + Coordinate recruiting activities, candidate interviews, and onboarding/offboarding processes for team members. + Maintain strict confidentiality and exercise independent discretion and judgment to solve complex problems. + Identify opportunities to improve processes and organizational health, enhancing calendar hygiene, meeting efficiency, and project tracking. **Executive Support & Special Projects** + Manage and execute special projects, including desk research and follow-up to ensure deadlines are met. + Achieve results independently, even in the absence of day-to-day guidance. + Create templates, draft briefing materials, PowerPoint presentations, communications, and business updates. + Ensure the Vice President is prepared for upcoming events and meetings. + Act as a trusted point of contact for internal and external stakeholders, facilitating communication and follow-up between senior team, VP, and board/committee members. + Oversee department materials and repositories (e.g., organization charts, distribution lists, conference rooms); lead the reimagination of SharePoint and related portals, ensuring version control and appropriate access. + Innovate and utilize current technology platforms, including Excel, Outlook, PowerPoint, Word, Concur, SharePoint, MS Teams, Workday, Our Source, and eMarketplace. + Leverage Microsoft Copilot and AI tools to optimize processes and efficiency across operations, programs, and teams. **Office & Team Experience** + Handle a wide range of administrative tasks, including file management and occasional HR or finance support. + Create an exceptional experience for team members, both in-office and virtually, ensuring a seamless, welcoming, and engaging environment. + Understand cross-regional cultural aspects and lead or operate effectively in diverse settings. + Collaborate with the Vice President to create cadence and end-to-end experiences for quarterly team meetings, monthly check-ins, and leadership gatherings; shape engaging agendas, templates, logistics, and entertainment. + Foster positive relationships with staff and management at all levels, often handling sensitive information. + Build strong relationships with Executive Assistants within the GHE and GCA organizations, as well as with EAs of other management team members, to ensure efficient collaboration and engagement. **Qualifications:** **Education & Experience** + Bachelor's degree required. + Minimum of six (6) years supporting senior management in a fast-paced, high-profile environment. **Skills & Competencies** + Strong verbal and written communication skills. + Superb organizational skills, attention to detail, and time-management abilities. + Ability to manage and complete multiple tasks efficiently. + Excellent interpersonal relationship skills with diverse constituents. + Proven ability to maintain confidential and sensitive information with discretion, integrity, and sound judgment. + Expert proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) and familiarity with collaboration and procurement platforms (SharePoint, MS Teams, Concur, Workday, ARIBA). + Self-motivated, hardworking, independent, and enthusiastic. + Demonstrated belief in Global Health Equity's mission and values. + Ability to anticipate executive needs and prepare information for review and action. + Experience supporting global organizations. + Strong leadership, collaboration, analytical, and problem-solving skills. + Sound judgment and discretion to independently assess and resolve complex situations and shift priorities as needed. + Positive, "can-do" attitude and commitment to Credo values. + Willingness to challenge the status quo, adopt best practices, and embrace change. + Comfort and efficiency in a dynamic, fast-paced, and often ambiguous environment. + Computer and systems savvy. **Other Requirements** + May require up to 10% domestic and/or international travel to other sites and locations. **Organizational Values** + Commitment to Johnson & Johnson's mission and values, with a focus on Global Health Equity. + Ability to foster an inclusive, collaborative, and innovative team culture Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Administrative Support, Business Writing, Communication, Customer Centricity, Data Capturing, Diary Management, Document Management, Execution Focus, Microsoft Office, Office Administration, Organizational Knowledge, Organizing, Presentation Development, Problem Solving, Professional Ethics, Travel Planning, Typing **The anticipated base pay range for this position is :** $74,550.00 - $119,542.50 Additional Description for Pay Transparency: This position is eligible for overtime. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year

The Associate Sales Representative provides short-term territory coverage under the direction of a Region Business Manager. This role involves planning and executing sales activities, delivering presentations to healthcare professionals, and using approved marketing materials to drive product awareness and sales. The position requires frequent travel (80%+), including overnight stays, and candidates must live near a major airport. Responsibilities also include maintaining compliance with reporting and regulatory standards, participating in training, and supporting business planning efforts. Essential Functions: Under close supervision of the RBM, achieve all territory management, call activity goals and performance objectives for geographical assignment(s) including but not limited to call activity, sample and resource utilization, target reach and frequency, and sales performance. Under close supervision of the RBM, maintain proficient knowledge of promoted product disease states and indications. Deliver proficient sales presentations to a defined list of current and prospective customers with a frequency based on assigned call goals. Implement the Amneal selling model and process principles, including the DiSC personality profile when engaging with customers. Complete pre and post call analysis which positively impacts customer interactions. Regularly review and analyze all available sales data and utilize developmental budget funds Under close supervision of the RBM, adhere to all compliance policies and guidelines. Develop a daily call schedule to ensure efficient and comprehensive coverage of territory which may include a certain number of calls per day/week. Under close supervision of the RBM, complete administrative reports and meet related deadlines. Ensure proper safeguarding and care for company assets (laptop, iPad, fleet vehicle. etc.). Maintain the stated expectations of number of calls per day defined as face-to-face interactions, with healthcare providers focusing on top target customers. Enter calls immediately into Veeva System via iPad and check/respond to email daily. Education: Bachelors Degree (BA/BS) Business or a related field - Required Experience: 1+ year Sales Experience or experience in a Customer-Facing or Customer-Focused role Skills: Strong communication and presentation skills - Intermediate The base salary for this position ranges from $60,000 to $75,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Maintenance Engineer will take ownership in all the maintenance, troubleshooting, and continuous improvement of manufacturing equipment and maintenance activities. They play a crucial part in ensuring smooth production of oral solid dosage forms and transdermal systems, including birth control patches. This role demands strong technical expertise, leadership in troubleshooting, and collaboration across departments to ensure operational excellence, equipment reliability, and compliance with cGMP standards. Essential Functions: Develop, implement, and optimize preventive and corrective maintenance programs to maximize equipment uptime and reliability. Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, and automation-related failures independently. Lead the maintenance, troubleshooting, and repair of sophisticated manufacturing equipment including tablet presses, coaters, mixers, dryers, slitters, packaging machines, and utilities. Manage and ensure accurate documentation of maintenance activities, maintenance plans, and equipment history within Blue Mountain Regulatory software adhering strictly to GMP and regulatory requirements. Lead or assist in equipment installation, qualification, and validation (IQ/OQ/PQ) activities, working closely with validation and quality teams. Support root cause analysis (RCA) and lead implementation of corrective and preventive actions (CAPA) related to equipment failures. Additional Responsibilities: Collaborate closely with production, quality assurance, engineering, and EHS teams to support seamless manufacturing operations. Manage external contractors and vendors, ensuring adherence to safety and regulatory standards. Maintain spare parts inventory levels and suggest reordering as needed. Ensure compliance with all health, safety, and environmental standards and company policies. Identify and implement continuous improvement initiatives related to equipment reliability, efficiency, and safety. Education: Bachelors Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Required Master Degree (MS/MA) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Preferred Experience: 3 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field. The base salary for this position ranges from $80,000 to $95,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Johnson & Johnson Innovative Medicine is searching for the best talent for the position of Senior Programming Lead to join our Integrated Data Analytics and Reporting team (IDAR). This is a hybrid position which can be based in either Spring House, PA, Titusville, NJ or Raritan, NJ. The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures. Position Summary: This role is responsible for providing expertise, planning and oversight of one or more programming trial activities of moderate to high complexity. The role makes decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams. This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects. The Senior Programming Lead position combines the expertise and responsibilities in their respective programming roles, making them an asset to IDAR's C&SP activities. Principal Responsibilities: * Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects. * Designs and develops programs in support of complex clinical data analysis and reporting activities. * Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer's guides. * Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies. * Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently. * Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches. * As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. * May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions. * Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives. Clinical Programming: * Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed. * Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities. * Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. * Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. * External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience and Skills Required: * Approx. 4+ years programming and or clinical data management experience with increasing responsibility preferably in pharmaceutical/clinical trial environment. * Knowledge of programming practices (including tools and processes). * Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required. * Expert CDISC Standards knowledge. * Experience in planning and coordinating programming activities and leading teams. * Experience working with cross-functional stakeholders and teams. * Experience in vendor management oversight. * Project management skills and knowledge of team management principles. * Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. * Demonstrated written and verbal communication skills. * This position offers the hybrid option and will be based in either Spring House, PA, Titusville, NJ or Raritan, NJ. (No fully remote option available for this role.) Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or internal employees contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $109,000 to $174,800. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. #LI-SL #JNJDataScience #JNJIMRND-DS #LI-Hybrid Required Skills: Preferred Skills: Advanced Analytics, Biostatistics, Clinical Trials, Collaborating, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy

The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners. The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives. Essential Functions: * Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles * Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction. * Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts. * Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements. * Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence. * 3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management.

The DEA Compliance Auditor will maintain all compliance regulations and laws that are required by the U.S. Drug Enforcement Administration as specified by (21 CFR 1300 to 1321.01) for Amneal's assigned facilities. Essential Functions: Execute DEA documents which include, but are not limited to: Registration applications, renewals, and updates. Drug code additions. Import and export permit application forms. DEA 222 order forms for procurement of API, USP standards, RLDs, etc. Ensure that periodic inventories and reports required by the Drug Enforcement Administration and various state reports are accurate and submitted to the Director DEA Compliance promptly. These reports include "ARCOS", Biennial inventory, and Year End Reports. Ensure effective control measures and Compliance SOP guidelines are being followed at all facilities. Coordinate destruction of scheduled materials, waste, or by products. Conduct periodic audits and manage Amneal controlled substance record keeping, inventory, and security systems to prevent diversion of controlled substance raw materials and finished products. Oversee suspicious order monitoring process. Oversee the handling of Loss/Theft filling reports with local DEA office when needed. Additional Responsibilities: Coordinate investigations of suspicious controlled substance orders from consignees with Amneal NY DEA Compliance section.Coordinate priorities with elements of Amneal's logistics/shipping team to ensure that controlled substance products are transported in the manner prescribed by DEA regulations to prevent diversion. Assume other duties as assigned. Education: Bachelors Degree (BA/BS) with 2 yrs of experience - Required Experience: 2 years or more in Regulatory, Compliance, Law Enforcement or Military equivalent. Skills: Great Time management - Advanced Excellent communications, writing and organization skills, with good people skills. - Advanced Analytical thinker with the ability to analyze information and uncover errors and inaccuracies during inventory reviews or audits. - Advanced Microsoft Office skills particularly Word and Excel - Intermediate Specialized Knowledge: Knowledge and experience in FDA and DEA regulations, particularly 21 CFR 1300 to 1321.01Basic software skills. Knowledge and experience in the areas (min 3) of ARCO, NYSDOH, YERS, DEA documents to include registration application, import/export permit application and quota request forms. The base salary for this position ranges from $60,000 to $70,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run. Essential Functions: All Functions of QA Inspector I, Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintenance of standard weights required to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards. Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room. Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Plus the following: Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions) Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step Verification of functionality of all the equipment and associated controls during the batch run Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log and disposition of samples. Additional Responsibilities: Disposition of rejected material and returned drug products as per SOP Performs environmental monitoring in accordance with established schedule (where applicable) Perform applicable testing and prepare report for customer complaints Other duties that management may from time to time assign. Education: High School or GED - Required Experience: 2 years or more experience in QA field - Required 2 years of experience in pharmaceutical industry experience - Required Skills: High energy level and organizational skills. - Advanced A certain degree of creativity and latitude - Advanced Basic computer skills ( Word and Excel) - Intermediate Specialized Knowledge: Good basic math knowledge and excellent attention to details. Records observations for improving processes. The hourly rate for this position ranges from $21.00 to $27.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Automation Engineer is responsible for overseeing and optimizing automation systems to improve production efficiency and reduce operational costs. This position involves designing, integrating, and implementing advanced hardware and software solutions within pharmaceutical manufacturing facilities. Essential Functions: Develop Control Systems based on coordination with OEM, in order to automate upstream and downstream processing equipment, including Mixers, Coaters, Pouches, Cartoners, Packaging Lines, Laboratory equipment, facility systems, stability Chambers, BMS, CIP (Clean in Place) and SIP (Steam in Place), Water System Controls, Tablet Press, Fluid Bed Dryers, Granulators, Vision System etc. Perform programming, qualification and validation of digital process automation systems. Provide 24x7 on-call Automation Support, including technical support and troubleshooting functions. Perform formal systems acceptance testing, including software simulation and hardware and equipment acceptance in pharmaceutical manufacturing facilities. Properly complete documentation for accurate recordkeeping, according to the Engineering Department's procedures, Assist with updating departmental procedures; monitor equipment, and ensure preventative maintenance is being done, handle calibration monitoring, engineering analysis. Assist with training coworkers on using equipment. Read, understand, verify and develop P&ID, Engineering Layout, Engineering Drawings and Engineering documents. Implement projects according to Good Automated Manufacturing Practice (GAMP) guide for validation of automated systems in pharmaceutical manufacture. Handle logistics and coordination of electrical construction activities as per engineering standards, vendor development, with the various departments like manufacturing, QA, QC, R&D for the engineering and Validation Aspects; maintain VMP and other GMP documents, Support Process Validation and Development Studies. Coordinate and ensure Safety Aspects. Perform hands on field installation, operational start-up, calibration, and commissioning activities. Support Change Control Management, updating documentation for client, including test plans and production implementation. Apply batch coding standards to automation process, including design of batch operations, unit procedures, and procedural recipe components to aforementioned processes. Additional Responsibilities: Assists with engineering projects and performs other duties as assigned. Education: Bachelors Degree (BA/BS) Electrical Engineering or Related Field - Required Masters Degree in Electrical Engineering or Related Field - Preferred Experience: 3 Years of Experience working with hydraulics, pneumatics, programmable logic controllers, electrical circuits, electrical machinery and human-machine interfaces within industrial and manufacturing plant, food or pharmaceutical processing facilities. Skills: Proficient with MS Office. - Intermediate Proficiency with Computer Aided Design Software (Autocad), Proficiency with MS Project Software - Advanced Technical writing skills. - Advanced Oral and written communication skills. - Advanced Must be able for follow direction and execute assigned work independently, after initial training is completed. - Advanced Ability to work both independently and in conjunction with a team - Advanced Specialized Knowledge: Fully comprehend, verify, and develop P&ID, Engineering Layout, Electrical/Controls Diagram, Engineering Drawings and Engineering documents, HMI, SCADA, VFD and PID Controller Programming Project Management The base salary for this position ranges from $95,000 to $110,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Associate Process Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision. Essential Functions: Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements Prepare and review manufacturing batch record and other engineering qualification documents as required Coordinate/oversee the development of new processes or troubleshoot existing ones Review Annual Product Review reports and plot trend analysis & APR reports Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) Assist in various audits Additional Responsibilities: Performs other functions as required or assigned. Complies with all company policies and standards. Initiation of Change Controls and Planned Deviations when required Reviews manufacturing/ Packaging batch records and Engineering qualification documents Performs other functions as required or assigned. Complies with all company policies and standards. Education: Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred Experience: 1 year or more in Pharmaceutical/Manufacturing Industry Skills: Excellent verbal and written communication skills. - Advanced Proficiency in MS Word/Excel/Powerpoint. - Advanced Multi-tasking. - Specialized Knowledge: Basic Analytical Knowledge desirable. 21 CFR, cGMP, basic manufacturing process knowledge. The salary for this position ranges from $65,000 to $80,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Job Description Medical Assistant/Phlebotomist Title: Medical Assistant/Phlebotomist Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Job Summary: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators; Associate Director Clinical Operations; and Clinical Research Coordinators to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services. Duties & Responsibilities: Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators. Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develop a strategy for implementing study procedures in compliance with study protocols. Develops proficiency in the use of in-house eSource system (Clinspark). Assist Clinical Research Coordinators in any task as needed including, labeling, taping (e.g., sample collection and transfer tubes, safety labs, urine cups, etc.) and record and transcribing study data in the source documents. Maintains an up-to-date training record for SOP's and study conduct. Minimum Job Requirements & Qualifications: Educational/Training Requirement: Minimum High School Diploma or Equivalency Diploma (GED) Experience: 1 years' experience in a related medical position, certification as a medical assistant (CMA) preferred. Licenses/Certifications (if applicable): Certified Medical Assistant Certified Phlebotomist Knowledge, Skills, and Abilities (KSAs): Experience with EMR, MS Word, Excel, MS outlook. Work Environment: The position requires work in alternating shifts, e.g., mornings, afternoons, overnights, and weekends. Potential for exposure to radiation for radiolabel study. Salary and Benefits: Frontage Laboratories offers competitive compensation and benefits package. Salary: $20 - $24 per hour Benefits: 401k Employer Match Medical Insurance -High Deductible/HSA -Low PPO -High PPO Dental Insurance -Low PPO -High PPO Vision Insurance FSA (Medical, Dependent Care, and Commuter) Short Term Disability Long Term Disability Life Insurance Generous PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead's medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration. The Associate Director, PS Medical Device Safety will be a medical device / combination product expert who supports safety oversight and provides technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance and trending / signal management for medical devices and combination products worldwide. The role would suit someone with passion for patient safety, strong strategic thinking, communication and analytical skills, broad PV and medical device / combination product experience and an enthusiasm for understanding the business needs. Key Responsibilities Responsibilities include, but are not limited to: Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics. Review device cases / complaints to ensure that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database. Develop training and standards for case processing and safety reporting. Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation. Support writing, review, and submission of applicable device contribution in aggregate reports (PSUR/PBRER, PADER). Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, as well as device trending and signal management for combination products. Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies. Collaborate with cross-functional team in device risk management activities including identification and reduction of risks associated with Gilead's medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product. Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required. Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally. Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS. Link with PS Alliances team regarding device requirements needed in PV agreements with License Partners. Collaborate with cross-functional teams in the preparation and/or support of internal audits and regulatory agency inspections; reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for medical device / combination product. Develop solutions to a wide range of complex problems, ensuring solutions are consistent with organization objectives. Foster a culture of collaboration and communication to drive business objectives. Drive a culture of continuous improvement to enhance PS processes and safety oversight. Stay abreast of industry trends, emerging topics, and best practices in the medical device / combination product space. Basic Qualifications BA/BS with 10+ years' relevant experience OR MA/MS/MBA with 8+ years' relevant experience OR PhD/PharmD with 5+ years' relevant experience Preferred Qualifications Health care professional degree preferably Nursing or Biomedical Engineering degree. Extensive medical device / combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities. Thorough understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these requirements into medical device safety processes, in particular risk management, device vigilance / safety reporting and post-market surveillance preferred. Significant experience in navigating a matrix organization. Track record of successfully leading complex, large scale, time-sensitive projects. Strong relationship building skills, and ability to collaborate, influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs. Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations. Ability to prioritize and manage across multiple competing projects. When needed, ability to travel. The salary range for this position is: Other US Locations: $177,905.00 - $230,230.00. Bay Area: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Technology Product & Platform Management **Job Sub** **Function:** Reliability Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** New Brunswick, New Jersey, United States of America **Job Description:** **Employer:** Johnson &Johnson Services, Inc. **Job Title:** Lead - Technology Services Application Maintenance **Job Code:** A011.8188 **Job Location:** New Brunswick, NJ **Job Type:** Full-Time **Rate of Pay:** $135,000 - $155,000 **Job Duties:** Design, deploy, operate, automate, and continuously improve financial and legal service product applications. Work to keep revenue and reputation-critical systems highly available and reliable by measuring and monitoring availability, performance, and overall system health. Perform production readiness reviews and ensure operational resource capacity based on business criticality of the application. Perform Service Maintenance activities such as Request Management, Incident and Outage Management, Event Management, and Service Level Management. Perform service transition activities such as Change Management, Release Management, Cutover Transition to Go-Live, Knowledge Management, and Continuous Service Improvement. Collaborate with business partners, Technology Product Owners, build team, Developer/SaaS vendors, and architects to drive solutions to build stronger and more reliable products. Collaborate with TPOs and other stakeholders to engineer solutions through automation, preventative measures that deliver high quality and high availability corporate business technology products. Accountable for delivery and maintenance of SLA by validating, classifying, and responding to service requests according to SLA. Maintain compliance and audit requirements, including completing compliance assessments. Collaborate with various stakeholders for incident and outage management, including major incidents and timely resolution according to SLAs. Responsible for Change Lifecycle, and contribute to the Release Management Lifecycle, including release review and validation, planning, building and configuring, testing and acceptance, operational readiness, and deployment. Monitor and measure the quality of IT operations, benchmark metrics, perform analysis and identify improvement actions. Ensure ticket volumes for the consumption-based model remain within budget. May telecommute. **Requirements:** Employer will accept a Master's degree in Information Systems, Applied Computer Science or related field and 2 years of experience in the job offered or in a Lead - Technology Services Application Maintenance-related occupation. This job posting is anticipated to close on 1/9/2026. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $135,000 - $155,000 annually Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Finance Job Sub Function: Investor Relations Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America Job Description: Johnson & Johnson is hiring for a Senior Analyst, Investor Relations located in New Brunswick, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/. This individual will provide financial analysis, analytics and insights to the Investor Relations team and J&J executive management. This role will work closely with the finance team to analyze and frame financial results, important metrics, and other relevant information for use during the quarterly earnings announcement and conference call, and throughout the quarter during regular discussions with management and the investment community. This role will include collaboration with, and exposure to, senior leadership of Johnson & Johnson on a regular basis. The role will report to the Senior Manager of Investor Relations. Responsibilities Include: * Manage quarterly investor relations reporting requirements from operating companies. * Assist in compiling management reporting and preparation materials for J&J executive management team and earnings calls. * Own and maintain the external investor relations website. * Lead competitive monitoring and reporting, including development of competitive flash reports, dashboards, and leadership briefings. * Analyze broker consensus models and perform comparative analytics versus internal forecasts to provide insights that inform IR strategy. * Prepare and present Investor Relations materials (presentations, management briefing documents, etc.) for investment community interactions (conferences, roadshows, etc.). * Manage the Investor Relations Question & Answer (Q&A) database. * Prepare for annual business reviews and support recurring Investor Relations reporting processes. * Supervise and develop an FLDP analyst. Qualifications: * A minimum of a bachelor's degree is required. Accounting, Finance, or Economics is preferred. * Minimum of (3) three years Finance, Accounting, Leadership, or related Business Experience required. * Professional Certification (CMA, CPA) and/or MBA preferred. * Excellent analytical skills and presentation skills are required. * Intermediate to advanced MS Excel required. * Ability to challenge business partners and propose alternative solutions required. * This position is located in New Brunswick, NJ, and may require up to 5% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Annual Report, Business Behavior, Business Communications, Coaching, Communication, Competitive Landscape Analysis, Data Reporting, Financial Analysis, Financial Modeling, Financial Risk Management (FRM), Investor Relations, Market Research, New Program Development, Problem Solving, Relationship Building, Researching, Socially Responsible Investment The anticipated base pay range for this position is : $79,000-$127,650 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ******************************************** The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Pharmaceutical Process Operations Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for a CAR-T, Manufacturing Supervisor, 2nd shift - Wednesday to Saturday, (Thursday to Saturday bi-weekly) to join our Team in Raritan, NJ. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in the manufacturing of our pharmaceutical products? Apply today for this exciting opportunity! The CAR-T Manufacturing Supervisor is responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Their job duties will be performed within a team-based environment, on an assigned production shift schedule. Key Responsibilities: * Lead and supervise a specific Processing Manufacturing Unit within the CART process operations (Day 0, Cell Culture, Day 10 or Component Prep) * Lead daily shift operations meetings (Tier Meeting) where you would assign individuals their daily production task to complete and ensure compliance and successful completion of work-related tasks. * Work closely with operations personnel on the production floor to provide clear guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. * Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and handle change controls. * Work with Operations Manager to help oversee the development of production personnel, provide input on personnel performance. * Build positive relationships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor. * Support the development of manufacturing processes and work with cross-functional teams to drive continuous improvements and efficiencies within cell therapy Operations. * Participate in various department projects and handle challenging priorities in a fast paced and dynamic environment * Participate in production runs in critical situations when needed. Supervisors should be qualified in the process they provide oversight to, to better understand Team challenges * In the event production runs past shift end time a supervisor will be required to stay with their processing unit until Batches are completed Qualifications: Education: * Minimum of an Associate's, Vocational, Technical/Trade, or equivalent degree/certificate is required; Bachelor's degree or focused degree in Science, Engineering, or related field preferred Experience and Skills: Required: * Minimum 2 years of relevant work experience Leading in Operations or Manufacturing within a cGMP environment (biotech/biopharma or engineering) * Experience in Aseptic Manufacturing & Aseptic Techniques * Excellent communication and interpersonal skills * Advanced Experience in Microsoft Office tools (Word, Excel, PowerPoint, and Outlook, MS Channels, Teams, SharePoint) * Advanced Computer Literacy and fully able to work in Electronic Systems such as Workday, SAP, Atlas, S4Hana, Elims, MES, Binocs, EMS, Scheduling Tools etc. * Ability to Gown into Clean Room Attire to provide shop floor oversite of operations personnel (Scrubs, Safety Glasses, Hair Net, Face Mask, Clean Room Shoes, Grade B Suit) * Required to Work on Holidays if they fall on shift days * Shift is Wednesday to Saturday and then Thursday to Saturday Bi-Weekly. Hours will be 1PM-1AM or 1PM-12:30AM and are subject to be adjusted in the event of business need. * Requires ability to lift up to 25 lbs and to stand for extended periods of time * May require up to 10% domestic travel to other sites/locations Preferred: * Experienced in working in a lab as either as a Lab Technician, Operations Lead, Manufacturing Specialist or Manufacturing Operator * Experience in an aseptic manufacturing environment (Clean Rooms & Laboratories) * Operational Excellence and/or Lean Manufacturing experience, training, or certification Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Compliance Management, Data Compilation, Data Savvy, Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Standards, Mentorship, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Project Management, Technical Credibility The anticipated base pay range for this position is : $79,000 to $128,000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization Ensure appropriate strategy/solution is proposed to clients Monitor actions and results against plans Lead client visits to the Frontage facilities Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities Monitor sponsor satisfaction by regular communication with the clients/sponsors Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (sales f orce) system Represent Frontage at trade shows and other meetings Education, Skills and Experience Required: BS degree or above, life science preferred. 3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services. Solid understanding of the principles of drug discovery and development. Knowledge and experience in DMPK & Safety Toxicology Knowledge and understanding of FDA, GCP, and ICH regulations and guidance Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel. Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities. Excellent oral and written communication skills. Ability to travel. Established industry client network is a plus. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Career CategoryMedical AffairsJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr. Medical Science Liaison - Cardiovascular Metabolic Territory will cover Southern NJ and Delaware What you will do Let's do this. Let's change the world. This is a field-based position for the Sr. Medical Science Liaison therapeutic area within the US Medical team. In this vital role, you will interact with cardiometabolic opinion leaders and healthcare decision-makers to communicate and advance the scientific platform as aligned with Amgen's organizational goals and objectives. Engage with healthcare partners to educate and communicate clinical and scientific data to advance the scientific platform as aligned with Amgen's organizational goals and objectives. Educate and communicate clinical value, outcomes, and economic data to payers, providers, key partners, advocacy, and access enablers Provide in-depth clinical and economic support to payers, IDNs, and formulary committees, while also sharing insights with key internal collaborators on customer trends in interpreting and using value evidence, reimbursement, and payer policy. May serve as main medical point of contact at prioritized local payer, regional payer, and IDN accounts Respond to unsolicited inquiries consistent with the MSL compliance standards Provide and/or present field observations and insights to internal collaborators Implement a scientific engagement plan according to annual MSL goals and metrics Develop and implement local OL plans in line with SEP Support speaker training as requested and ensure the speakers are updated on new data Support Amgen-sponsored research and may serve as a study lead Educate potential investigators on the submission process for investigator-sponsored studies Lead and/or participate on project teams that support MSL strategies and tactics as delegated by MSL leadership Lead and support congress activities in accordance with the strategy. May serve as the congress lead. Compliantly collaborate with cross-functional colleagues. May serve as the main point of contact Maintain clinical savvy and expertise and ensure the timely completion of assigned training. May serve as a training lead, new hire mentor, and/or international MSL mentor or trainer Advance MSL value proposition, identify gaps, achieve results, and set an example for others to follow by consistently demonstrating Amgen values and leadership attributes Demonstrate tact and professionalism when communicating and interacting with individuals. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The adaptable professional we seek is a key collaborator with these qualifications. Basic Qualifications: Doctorate degree & 2 Years of Medical Affairs experience Or Master's degree & 6 years of Medical Affairs experience Or Bachelor's degree & 8 years of Medical Affairs experience Preferred Qualifications: Pharm. D., Ph.D., M.D., or D.O. (other doctoral degrees are considered.) 2+ years of industry experience in Scientific or Medical Affairs at a biotech or pharmaceutical company 2 + years in a medical science liaison role in a biotech or pharmaceutical company Experience in a medically related field can include post-doctoral training (i.e., residencies and/or fellowships) Cardio-metabolic expertise preferred What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 189,792.00 USD - 213,579.00 USD

Clinical Research Nurse (per diem) Title: Clinical Research Nurse (per diem) Reports To: Executive Medical Director and Principal Investigator Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: We are seeking a licensed and detail-oriented Clinical Research Nurse in support of clinical trials conducted at Frontage Clinical Services. in support of clinical trials conducted at Frontage Clinical Services. responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services site in Secaucus. Responsibilities: Assist Clinical Study Coordinators in any task as needed. Administer Medications (including IV administration route) per doctor's and protocol instructions. Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators. Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness. Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol. Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor. Responsible for maintaining emergency medication in the crash cart. Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator. Assists in the screening of research subjects to evaluate their eligibility for a clinical study. Creates and performs QC procedures. Assists in the reconciliation of IPs and maintaining accountability. Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.) Shows desire and initiative to increase knowledge and skills in clinical research. Education and Requirements Bachelors in Science in Nursing. Registered Nurse in the State of New Jersey Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel. 1-3 years' experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary, or mandatory on-job training will be required. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners. The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives. Essential Functions: Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction. Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts. Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements. Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence. 3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management. Qualifications Education: Bachelors Degree (BA/BS) relevant field (e.g. business or economics) - Required Experience: 10 years or more in Pharmaceutical/biotech contract operations, contract administration and contract management 3 years or more in Collaborating directly with legal teams and attorneys; and field sales leaders Skills: Able to rapidly develop and maintain successful relationships with leaders and decision makers most likely at C-Suite level. - Advanced Strong negotiation skills. - Advanced Able to work well under pressure and in appreciation of pre-defined and often aggressive timelines. - Advanced Excellent written, organizational and verbal communication skills a must. - Advanced Computer literate with MS Office products including PowerPoint, Word, and Excel. - Advanced Understanding or background in biosimilar pharmaceutical products. - Intermediate Leadership skills. - Intermediate Specialized Knowledge: Microsoft Office - PowerPoint, Word, Outlook, Advanced Excel skills Strong technical skills in applications such as MS Excel, MS PowerPoint, MS OneNote and other Microsoft Office suite tools The annual salary for this position ranges from $160,000-185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.