Quality Control Scientist jobs at Amneal Pharmaceuticals - 280 jobs

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.

Are you passionate about science and organization? We're looking for a hands-on scientist who can also drive project coordination across R&D and analytical initiatives. This role blends technical expertise with leadership in planning and communication. What You'll Do Track and manage R&D and analytical projects, ensuring timelines and priorities are met. Maintain project dashboards and prepare concise progress updates for leadership. Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability). Collaborate with QA, Regulatory, and Operations to align deliverables. Recommend process improvements and help implement standardized tools. What We're Looking For Education: Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Experience: 3-6 years in pharmaceutical R&D, analytical chemistry, or formulation science. Familiarity with HPLC and method development. Strong organizational and communication skills. Comfortable balancing lab work with coordination responsibilities. Why Join Us Competitive salary + comprehensive benefits. Health, dental, vision coverage. Retirement plan with company match. Paid time off and holidays. Collaborative, science-driven environment.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **QC Scientist I Raw Materials** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. **Essential Job Responsibilities:** + Develop/author/revise technical reports and laboratory procedures (SOPs, methods) + Execute and troubleshoot raw material testing in support of production activities + Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures + Design and perform testing in support of method transfer/validation/qualification/verification + Review/authorize data and perform analysis and interpretation of test results and trends + Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations + Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration + Support and mentor junior team members + Collaborate with other network sites to share best practices + Other duties as required **Quantitative Dimensions:** The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. **Organizational Context:** The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Rensselaer, NY, USA Full-time ** _At Eurofins, your work supports global health and safety. We invest in your professional growth with opportunities to advance in the biopharmaceutical industry, backed by collaborative teams, work-life balance, and competitive benefits._ _Eurofins Scientific is a global leader in life sciences, providing analytical testing across industries-from food and water to pharmaceuticals and advanced materials. We help the world's top companies ensure their products are safe, authentic, and accurately labeled._ **Job Description** **Laboratory Responsibilities** + Performs all duties relevant to the Quality Control Raw Materials - Utility Testing analyst position as required. + Testing including pH, Conductivity, Nitrate identification Total Organic Carbon, and Appearance + Receiving, handling, and disposing of samples + Calibrates or verifies calibration of instruments/devices before use. + Accurately records test results and reports any quality anomalies + Maintains laboratory supplies, media, and reagents inventory and performs laboratory housekeeping as assigned + Uses Laboratory Information Management System (LIMS) for samples. + Ensures excellent customer service to clients Participates in required training activities + Complies with all pertinent regulatory agency requirements + Training new employees on some GMP related responsibility relevant to the supervised functional areas where appropriate + Communicating findings and recommendations at group meetings + Participating in and/or leading cross-functional teams to support optimal client services + Independently investigating team quality deviations and preventing reoccurrences in support of QC operations + Schedules above tasks on a weekly, monthly, and quarterly basis + A strong work ethic and ability to meet physical demands including, but not limited to, routinely lifting objects of 25 lbs. or more, walking and standing for extended periods of time, pushing or pulling carts and drums and bending down or reaching for supplies. **Leadership Responsibilities** + Supports and monitors performance of team of employees + May participate in new hire interviews + Supports the on-boarding process of new employees + Participates in training of other employees. + Performs peer review of data. + Assists in coordinating equipment maintenance and calibration. + Disseminate administrative communications + Demonstrate and promote the company vision + Meet all quality and productivity metrics, and demonstrate strong teamwork and collaboration + Coordinate scheduling and allocation of responsibilities, and new hire on-boarding process + Coordinates training program **Qualifications** **The Ideal Candidate would possess:** + Laboratory experience + 1+ years of cGMP experience + Strong computer, scientific, and organizational skills + Excellent communication (oral and written) and attention to detail + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a client-facing environment + Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies + Excellent communication (oral and written) and attention to detail + Proactively plan and multitask to maximize productivity + Experience with LIMS preferred **Minimum Qualifications:** + Bachelor's degree in Life Sciences, or other science related degree concentration, or equivalent directly related experience + 1+ years previous leadership experience + Authorization to work in the United States indefinitely without restriction or sponsorship **Additional Information** The work schedule will be **Sun - Wed 7am-5:30pm** with overtime as needed. Candidates living within a commutable distance of Rensselaer, New York are encouraged to apply. **What we offer:** + Excellent full time benefits including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays + Compensation range: **$27 - $33** **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**

At Eurofins, your work supports global health and safety. We invest in your professional growth with opportunities to advance in the biopharmaceutical industry, backed by collaborative teams, work-life balance, and competitive benefits. Eurofins Scientific is a global leader in life sciences, providing analytical testing across industries-from food and water to pharmaceuticals and advanced materials. We help the world's top companies ensure their products are safe, authentic, and accurately labeled. Job Description Laboratory Responsibilities * Performs all duties relevant to the Quality Control Raw Materials - Utility Testing analyst position as required. * Testing including pH, Conductivity, Nitrate identification Total Organic Carbon, and Appearance * Receiving, handling, and disposing of samples * Calibrates or verifies calibration of instruments/devices before use. * Accurately records test results and reports any quality anomalies * Maintains laboratory supplies, media, and reagents inventory and performs laboratory housekeeping as assigned * Uses Laboratory Information Management System (LIMS) for samples. * Ensures excellent customer service to clients Participates in required training activities * Complies with all pertinent regulatory agency requirements * Training new employees on some GMP related responsibility relevant to the supervised functional areas where appropriate * Communicating findings and recommendations at group meetings * Participating in and/or leading cross-functional teams to support optimal client services * Independently investigating team quality deviations and preventing reoccurrences in support of QC operations * Schedules above tasks on a weekly, monthly, and quarterly basis * A strong work ethic and ability to meet physical demands including, but not limited to, routinely lifting objects of 25 lbs. or more, walking and standing for extended periods of time, pushing or pulling carts and drums and bending down or reaching for supplies. Leadership Responsibilities * Supports and monitors performance of team of employees * May participate in new hire interviews * Supports the on-boarding process of new employees * Participates in training of other employees. * Performs peer review of data. * Assists in coordinating equipment maintenance and calibration. * Disseminate administrative communications * Demonstrate and promote the company vision * Meet all quality and productivity metrics, and demonstrate strong teamwork and collaboration * Coordinate scheduling and allocation of responsibilities, and new hire on-boarding process * Coordinates training program Qualifications The Ideal Candidate would possess: * Laboratory experience * 1+ years of cGMP experience * Strong computer, scientific, and organizational skills * Excellent communication (oral and written) and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a client-facing environment * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies * Excellent communication (oral and written) and attention to detail * Proactively plan and multitask to maximize productivity * Experience with LIMS preferred Minimum Qualifications: * Bachelor's degree in Life Sciences, or other science related degree concentration, or equivalent directly related experience * 1+ years previous leadership experience * Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information The work schedule will be Sun - Wed 7am-5:30pm with overtime as needed. Candidates living within a commutable distance of Rensselaer, New York are encouraged to apply. What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * Compensation range: $27 - $33 Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. 2. Maintain detailed and comprehensive documentation of all work performed. 3. Stay current with the scientific literature, particularly in areas that may affect companys product line, existing processes or potential commercial opportunities. 4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. 5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. 6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. 7. Provide support to QA/QC by writing analytical SOPs. 8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. 9. Provide monthly report on progress of work to the department head. 10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. 11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. 12. Work closely with Synthesis group and support on routine analysis. 13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. 14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. 15. Work closely with R&D team to answer DMF deficiencies and customer queries. 16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). 17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. 18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. 19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. 20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. 21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. 22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. 23. Seek out opportunities for professional development. 24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. 25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. 26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. 27. Other duties as assigned. **Position Requirements:** + B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. + Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. + Ability to communicate effectively through verbal, written, presentation and computer modes of expression. + Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). _The presently-anticipated base compensation pay range for this position is $102,500 to $125,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist II or III - Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life's many other commitments and opportunities.

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE Responsible for assuring the accurate analysis of incoming raw materials, bulk liquids, and finished products utilizing Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak's Test Methods (NPTM) Good Laboratory Practices (GLPs), and Good Manufacturing Practices (GMPs). Assures tested raw materials, bulk liquids, and finished products have met the required specification criteria prior to release. Investigate out of specification results to determine final disposition. Maintain accurate, complete and traceable documentation related to analysis and disposition. Ensure the effective and efficient functioning of the Analytical Laboratory. Designate appropriate and trained personnel to perform required tasks. Review documentation to ensure adherence to internal and external requirements ESSENTIAL FUNCTIONS AND BASIC DUTIES Testing Requirements: Performance of diversified chemical testing as needed by using current USP, Standard Operating Procedures (SOPs), Work Instructions (WIs), (NPTM on raw materials, bulk liquids, and finished products. The testing may include but is not limited to: pH determination, viscosity, refractive index, specific gravity, etc. Conduct wet chemical titration to determine the percentage of activity on various solutions and raw materials, bulk liquids, and finished products. By the use of instruments (GC, HPLC, IR, UV, Auto-titrator, etc.) determine the percentage of various components as required by specifications. Perform identification of various chemicals or formulations as per methodology USP/NF and other test requirements Coordinate release of liquid batches including designation of reassay/expiration date. Assist in the sampling, testing and release of raw materials when needed Determine the toxicity and pH of waste tanks at designated intervals REPORTING & ANALYSIS: Ensure that all results are accurately recorded in appropriate laboratory logs or other designated forms Review all data generated by the laboratory associated with the manufacturing of Drug and OTC products Perform investigations into laboratory Out of Specification Results (OOS). Lab Maintenance: Ensure that all instruments that perform analysis are validated and calibrated. Ensure that all Analytical Methods utilized for analysis of Drug and OTC products, at the least, are validated according to International Standards Purchase analytical supplies Prepare solutions and titrants when required Clean laboratory at specified intervals Perform calibration, reading, and recording of instruments within the Analytical Chemistry Lab Prepare and maintain laboratory test solutions Additional Requirements: Determine products' disposition Complete necessary forms Lead, Direct and Train lower level Chemists ( I, II) in the use of instruments, methodology, SOPs, WIs, GLP, GMPs, etc. Furnish report to QC Lab Manager on a continuous basis. Assign workflow in the laboratory in conjunction with Analytical Chemist Senior Level. SPECIAL PROJECTS: Handles special projects and assignments as delegated (method transfer, method validation). PERFORMANCE MEASUREMENTS Test raw materials, batches, and finished products in a timely manner. Ensure release of raw materials, batches, and finished products are done efficiently. Maintain Lab cleanliness in a timely manner. Ensure proper new / refresher training of Analytical I Chemists. QUALIFICATIONS EDUCATION/CERTIFICATION: Bachelor's degree in Chemistry, Analytical Chemistry, or other related science REQUIRED KNOWLEDGE: Knowledge of Analytical techniques and able to incorporate them into daily tasks. Computer literate. Demonstrate ability to perform work accurately and be able to follow test methodology. Ability to perform well under pressure and work with minimum supervision. Some supervisor skills required. Able to delegate the required testing to competent and trained chemists EXPERIENCE REQUIRED: A minimum of 5 - 7 years' experience in a laboratory environment (Analytical Chemistry Lab preferred) At least three years in a regulated laboratory setting. WORKING CONDITIONS No hazardous or significantly unpleasant conditions. SALARY RANGE $80,000 - $90,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. QC Microbiology: The QC Microbiology Senior Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides support for strategic leadership and oversight of daily microbiological operations. The role will contribute to monitoring QC test method execution and the microbiological lifecycle management. The role is accountable for refining QC procedures across Gilead's small molecule and biologics manufacturing network, ensuring global cGMP compliance. Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead's LIMS. Department: Global Quality Control - GQC-Biologics and Small Molecules Job Responsibilities: Experience with Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends. In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. Demonstrated the ability to influence process and outcomes across functions. Willing to support future laboratory work. Basic Qualifications: PhD in Microbiology, Chemistry, Biochemistry or related field with 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR MS in Microbiology, Chemistry, Biochemistry or related field with 6+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR BS in Microbiology, Chemistry, Biochemistry or related field with 8+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR Associate's degree in Microbiology, Chemistry, Biochemistry or related field with 10+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR HS degree with 12+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. Preferred Qualifications: Preferred 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry. Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $157,590.00 - $203,940.00. 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 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** At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. **QC Microbiology:** The QC Microbiology Senior Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides support for strategic leadership and oversight of daily microbiological operations. The role will contribute to monitoring QC test method execution and the microbiological lifecycle management. The role is accountable for refining QC procedures across Gilead's small molecule and biologics manufacturing network, ensuring global cGMP compliance. Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead's LIMS. **Department:** Global Quality Control - GQC-Biologics and Small Molecules **Job Responsibilities: ** + Experience with Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends. + In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. + Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. + Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. + Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. + Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. + Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. + Demonstrated the ability to influence process and outcomes across functions. + Willing to support future laboratory work. **Basic** **Qualifications:** + PhD in Microbiology, Chemistry, Biochemistry or related field with 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR + MS in Microbiology, Chemistry, Biochemistry or related field with 6+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR + BS in Microbiology, Chemistry, Biochemistry or related field with 8+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR + Associate's degree in Microbiology, Chemistry, Biochemistry or related field with 10+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR + HS degree with 12+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. **Preferred Qualifications:** + Preferred 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. + Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry. + Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing. + Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. + Strong organizational and planning skills. + Shows excellent verbal and written communication skills and collaborative interpersonal skills. **People Leader Accountabilities:** + Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. + Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. + Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $157,590.00 - $203,940.00. 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. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Shift: Monday through Friday, 8:00AM - 5:00PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Make an impact. Build a career. At Pace , everything we do is built upon an unwavering commitment to making the world a safer, healthier place. We continually work to develop innovative practices that drive sustainability and empower our partners with accurate, quality data at every critical moment and milestone. That's why we need you - your curiosity, your talents, and your drive - to help us advance this important work, and your career. Find your place at Pace Join us as a Analytical Chemist, where you'll put your love of science to work in the Scientific Insourcing Solutions division. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace . A candidate for this role will support an organics laboratory in environmental services and equipment management. Compensation: $27.00 - 30.00 per hour NOTE: Location is Portsmouth, VA Responsibilities: Prepare chemical samples for analytical procedures (volatiles/non-volatiles) Conduct sample analysis using Gas Chromatography-Mass Spectrometry (GC-MS) and Gas Chromatography (GC) Clean, maintain, and calibrate laboratory instruments to ensure optimal performance Support the administration of air, water, and soil sample analysis using standard chemistry and biochemistry techniques Maintain accurate, detailed, and organized documentation of all laboratory activities and results Requirements: Minimum requirement: BS degree in Chemistry, Biology, Biochemistry, or a related degree 1-2 years of GC (Gas Chromatography) and ICP (Inductively Coupled Plasma) experience Able to handle multiple projects concurrently, self-motivated, and results driven Mechanically inclined with experience using common hand tools Proficiency in Office 365 and other software preferred Able to communicate effectively Excellent organizational and task management skills Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

We are looking for a Sr Quality Control Scientist in the Technical Resources Department. This position performs assay development, characterization, optimization, transfer, validation, and investigations for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. As a Sr QC Scientist for Chemistry in the Technical Resources Department, a typical day might include the following: + Performs assay development/validation for QC. + Reviews new test procedures and assays. + Evaluates and bring in new methodologies/techniques when needed. + Facilitate assay transfer from R&D and to business partners + Organize analytical assay transfer internally and externally. + Set product specification. + Participates in technical troubleshooting and problem investigation. + Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. + Participates in training programs for analysts. This job might be for you if: + You have in-depth knowledge with HPLC based assays. + You like dealing with technical issues, troubleshooting, and constant change + You are a team player who can work with a variety of different people on different tasks + You have strong written and verbal communication skills + You enjoy mentoring and training others on systems, processes and problem solving + You enjoy working in a fast-paced environment and are flexible to changing requirements + You can take on new and sometimes ambiguous challenges and learn quickly To be considered for a Sr QC Scientist (Chemistry) Technical Resources role you must be willing and able to work onsite Monday-Friday, 8am-4:30pm. A PhD in Chemistry, Biochemistry, Biology, or a related field is required. Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred. Level is determined based on experience relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $77,600.00 - $126,800.00

We are looking for a Sr Quality Control Scientist in the Technical Resources Department. This position performs assay development, characterization, optimization, transfer, validation, and investigations for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. As a Sr QC Scientist for Chemistry in the Technical Resources Department, a typical day might include the following: * Performs assay development/validation for QC. * Reviews new test procedures and assays. * Evaluates and bring in new methodologies/techniques when needed. * Facilitate assay transfer from R&D and to business partners * Organize analytical assay transfer internally and externally. * Set product specification. * Participates in technical troubleshooting and problem investigation. * Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. * Participates in training programs for analysts. This job might be for you if: * You have in-depth knowledge with HPLC based assays. * You like dealing with technical issues, troubleshooting, and constant change * You are a team player who can work with a variety of different people on different tasks * You have strong written and verbal communication skills * You enjoy mentoring and training others on systems, processes and problem solving * You enjoy working in a fast-paced environment and are flexible to changing requirements * You can take on new and sometimes ambiguous challenges and learn quickly To be considered for a Sr QC Scientist (Chemistry) Technical Resources role you must be willing and able to work onsite Monday-Friday, 8am-4:30pm. A PhD in Chemistry, Biochemistry, Biology, or a related field is required. Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred. Level is determined based on experience relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $77,600.00 - $126,800.00

Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The person in this role will develop analytical techniques and conduct experiments to support the development of commercially viable lipid-peptide and lipid-protein formulations. In addition, the person will support formulation development efforts. This role is crucial for advancing our CMC program for the Gates project, as well as establishing analytical capabilities and in expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be hands on in the lab with strong technical knowledge in analytical science and will be mentored to assist in formulation development efforts. What are the key responsibilities? Analytical chemistry: Develop and optimization analytical methods for characterizing and controlling the quality the quality attributes of lipid-peptide and lipid-protein formulations. Support formulation development and design of experiment studies. Formulation science: Support formulation development efforts by participating in formulation runs with guidance form formulation science staff. Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs) Cross-Functional Collaboration: Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals. Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing. Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends. What Education and Experience are required? A degree in Chemistry, Analytical chemistry, Biochemistry or related field. 2-5 years of experience in analytical development or quality control. Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus. Experience in technical writing is required. Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus. Knowledge and experience in drug-device development, inhalation drug delivery is a plus. Excellent written and oral communication skills. What key skills will make you great at the role? Technical expertise: Proficiency in analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods. Experience with drug-device combination products is a plus. Understanding of laboratory procedures, equipment, software, and data analysis. Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance. Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives. Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment. Compliance and safety: Ensure a safe and complaint work environment. Training, procedures, quality: Ensure up to date training on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.