Manager Quality Control (Analytical Testing)

Job description

Career CategoryQualityJob Description Join Amgen's Mission to Serve Patients At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact. Manager Quality Control I (Analytical Testing) What you will do Under minimal supervision, the Manager Quality Control will be responsible for overseeing day to day activities in analytical testing (including but not limited to raw material and utility testing, in-process, release, and stability testing of product such as analytical chemistry, bioassay, immunoassay tests etc.). The Manager Quality Control will collaborate with the global Amgen QC network and provide on-site support and collaboration for both biologics and small molecule manufacturing. Laboratory Operations Lead day-to-day analytical testing activities supporting raw materials, utilities, in-process controls, release, and stability testing. Ensure timely execution and completion of testing schedules to support manufacturing and product release requirements. Manage laboratory resources, staffing, workload prioritization, and capacity planning. Provide technical oversight for analytical methodologies. Ensure laboratory equipment, systems, and facilities remain qualified, calibrated, and maintained in a compliant state. Quality and Compliance Ensure laboratory operations comply with cGMP, regulatory requirements, data integrity principles, and internal quality standards. Review and approve analytical records, laboratory investigations, deviations, CAPAs, change controls, and quality documentation. Ensure prompt escalation, investigation and resolution of laboratory events, atypical results, OOS/OOT investigations, and compliance issues. Maintain a state of inspection readiness and support regulatory inspections, audits, and quality assessments. Represents the quality unit during audits and inspections Supports internal/external audits and inspections as part of the audit/inspection management team Drive quality risk management and continuous improvement initiatives. Leadership and People Management Lead, coach, and develop a team of analysts and senior analyst(s). Establish clear performance expectations and development plans. Ensure personnel are appropriately trained and qualified to perform assigned activities. Foster a culture of quality, safety, accountability, and continuous learning. Technical and Business Support Oversee site method validation, method transfer, verification, and lifecycle management activities. Provide technical expertise for troubleshooting analytical methods, instrumentation, and laboratory processes. Partner with Manufacturing, Quality Assurance, Process Development, Engineering, EHSS, and Global QC networks to resolve complex quality issues. Support new product introduction (NPI), technology transfers, and process improvement projects. Continuous Improvement Lead operational excellence and Lean initiatives to improve laboratory efficiency and effectiveness. Monitor laboratory performance metrics and implement actions to improve cycle times, right-first-time performance, and compliance outcomes. Standardize processes and share best practices across local and global QC networks. What we expect of you Doctorate degree OR Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related discipline and 2 years of directly related experience OR Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related discipline and 4 years of directly related experience OR Diploma in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related discipline and 8 years of directly related experience Minimum 5 years of Quality Control Analytical Operations experience in a GMP-regulated pharmaceutical or biotechnology environment. Previous experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods. Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment Strong knowledge and practical experience in: HPLC / UPLC GC / HS-GC FTIR UV-Vis Spectroscopy Karl Fischer Titration TOC, Conductivity and pH testing Capillary Electrophoresis Compendial testing Raw material testing Stability programs Laboratory computerized systems (LIMS, CDS, ELN) Experience in biologics analytical techniques such as: ELISA Cell-based bioassays Host Cell Protein testing Potency assays Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment Ability to lead diverse teams Good communication skills (technical writing and verbal communication/presentation) Ability to work in cross-functional and multisite teams Interact effectively with variety of communication and working styles Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality. Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. What you can expect of us As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally. Apply now and help transform the lives of patients while transforming your career. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .