Process Development Sr Scientist
Amgen
Summary
Join Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization. AS defines the favorable quality characteristics of the therapies Amgen produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organization's focus is developing and commercializing robust manufacturing processes across a wide range of biologic therapeutic modalities, including monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs).
Job description
What you will do
- 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 PhD OR PharmD OR MD [and relevant post-doc where applicable]
- OR Master's degree and 3 years of Scientific experience
- OR Bachelor's degree and 5 years of Scientific experience
Preferred Qualifications
- Doctorate degree with 5 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
- Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics
- Proficient in mass spectrometry techniques including intact mass and peptide mapping assays for characterizing biologic therapeutics
- Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF for biologics
- 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
- 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 skill
Requirements
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master's degree and 3 years of Scientific experience OR Bachelor's degree and 5 years of Scientific experience
- Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics
- Proficient in mass spectrometry techniques including intact mass and peptide mapping assays for characterizing biologic therapeutics
- Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF for biologics
- 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
- 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
- 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 skill
Benefits
- Retirement and Savings Plan
- Group medical, dental & vision
- Life and disability insurance
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models
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.