Process Development Principal Scientist

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), and live oncolytic viruses. This role primarily focuses on synthetic modalities.

Located in our Cambridge, MA office the PD Principal Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead and group lead) to teams developing commercialized manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.

Role Responsibilities:

• Act as a group lead handling a group of analysts in supporting process development. Provide career development mentorship to the team members.
• Act as an Attribute Sciences Team lead (ASTL) responsible for development of analytical control strategy and analytical support for synthetic Drug Substance (DS) and Drug Product (DP) through commercial process development to commercialization including process performance qualification.
• Act as an ASTL to provide analytical support including but not limited to reaction monitoring, starting materials and drug substance intermediates quality control, DS and DP release and stability. The role should have an in-depth understanding of analytical methodologies to support purity and impurity analysis, chiral purity analysis, residual solvent analysis, ion analysis, elemental analysis, dissolution analysis, and structural elucidation using a variety of techniques including but not limited to mass spectrometry, vibrational spectroscopy, and Nuclear Magnetic Resonance (NMR).
• Define the analytical target profile (ATP) for methods used to lead product quality. Based on the ATP, coordinate the development, qualification, optimization, validation and transfer of analytical methods to Quality Control or external Contract Manufacturing Organization (CMO)
• Handle activities at contract manufacturing and testing sites
• Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
• Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
• Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development
• Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

Basic Qualifications:

Doctorate degree and 3 years of life sciences industry experience

Or

Masters degree and 6 years of life sciences industry experience

Or

Bachelors degree and 8 years of life sciences industry experience

Preferred Qualifications:

• Advanced degree in Analytical Chemistry, Organic Chemistry, Material Science or related area
• 8 or more years manufacturing experience in development of analytical methods, method validation, method transfer, product characterization, process characterization related with synthetic process development.
• Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward process understanding and process control, separation science, structure elucidation and solid-state characterization guided and advised by knowledge of organic chemistry
• Understanding of analytical method development toward solid oral dosage support, including dissolution method development
• Experience in a wide variety of analytical and physicochemical techniques including chromatography (High- Performance Liquid Chromatography: HPLC, Gas Chromatography: GC, Capillary Electrophoresis: CE), mass spectrometry, Ultraviolet: UV, Nuclear Magnetic Resonance: NMR, Fourier Transform Infrared: FTIR, Raman, particle size determination, crystal characterization, dissolution, etc.
• Ability to develop, qualify, transfer and remediate methods for in-process, release and stability testing
• Experience in analytical testing requirements for immediate release and controlled release proven dosage forms, liquid formulation or lyophilized formulation
• Familiarity with and understanding of United States Pharmacopoeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development, etc.
• An understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (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, handling results against timelines
• Good interpersonal skills and ability to provide cross-functional leadership and mentorship to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. engaging and defending the Quality Target Product Profile
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
• Experience with protein-based and live modality therapies is helpful (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
• A self-starter and extraordinary teammate with strong leadership and decision-making skills, who can provide mentorship to junior staff
• Ability to multitask, optimally plan and follow through on sophisticated projects
• Someone who strongly values working on and leading teams

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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, or disability status.

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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, or disability status.