Career Category

Process Development

Job Description

Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.

Amgen’s 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.

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

Key responsibilities:

• Supervise and provide technical support for a team that provides analytical support for late stage product development
• Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
• Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
• Manage 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 Amgen’s 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 in Analytical chemistry, Biochemistry or equivalent experience OR
• Master’s degree and 6 years in Analytical chemistry, Biochemistry or equivalent experience OR
• Bachelor’s degree and 8 years in Analytical chemistry, Biochemistry or equivalent experience

Preferred Qualifications

• Doctorate degree with 7-10+ years in Analytical chemistry, Biochemistry or equivalent.  
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
• Successful track record of managing and developing team of scientist.
• Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques.
• Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
• Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
• Strong problem solving and effective multi-functional interpersonal skills.
• Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing
• Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, liquid formulation or lyophilized formulation
• Solid 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, managing deliverables against timelines
• Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing 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 beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
• A self-starter and team player with strong leadership and decision-making skills, who can provide mentorship to junior staff
• Ability to multitask, effectively plan and follow through on complex projects
• Someone who strongly values working on and leading teams

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