Process Development Sr Scientist
Amgen
Summary
Join the pivotal synthetic Attribute Sciences team, part of the integrated Pharmaceutical Attribute Sciences (iPAS) department, located in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
Job description
The analytical scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs across small molecules, synthetic peptides, siRNA, and synthetic components of conjugates.
Key Responsibilities
- Define analytical control strategies and implement methodologies to support the development of late-phase clinical programs, with a strong ability to articulate the challenges and complexities associated with analytical control strategy development.
- Develop, optimize, authorize and validate analytical methods for attribute understanding and characterization across synthetic modalities, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates.
- Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
- Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
- May lead activities and method transfer to contract manufacturing organization (CMO) or contract testing lab (CTL).
- Review and approve protocols, reports from CMO and CTL.
- Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
- May lead and mentor a small group of scientists.
Basic Qualifications
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientist experience OR Bachelor’s degree and 5 years of Scientist experience
Preferred Qualifications
- PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
- 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
- Experience in conjugates method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
- Strong understanding of synthetic molecule analysis and structure elucidation informed by knowledge of organic chemistry.
- Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
- Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
- Excellent communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
- Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents
Requirements
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientist experience OR Bachelor’s degree and 5 years of Scientist experience
- PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
- 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
- Experience in conjugates method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
- Strong understanding of synthetic molecule analysis and structure elucidation informed by knowledge of organic chemistry.
- Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
- Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
- Excellent communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
- Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents
Benefits
- Retirement and Savings Plan
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Time-off plans
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.