Process Development Sr Scientist

Amgen • Thousand Oaks, CA

1d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, you're part of something bigger, driven by a shared mission to serve patients living with serious illnesses. Since 1980, Amgen has pioneered biotech in the fight against tough diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients annually. Amgen is advancing a broad pipeline of medicines for cancer, heart disease, inflammatory conditions, rare diseases, and obesity. As part of the Amgen team, you will contribute to researching, manufacturing, and delivering innovative medicines to help people live longer, fuller, happier lives within a collaborative, innovative, and science-based culture. The Process Development Sr Scientist will join Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization. This department defines favorable quality characteristics of therapies and optimizes state-of-the-art analytical tools for development. The Pivotal PD organization focuses on developing and commercializing robust manufacturing processes for various therapeutic modalities, including synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers, and live oncolytic viruses. Located at the Thousand Oaks, CA office, the PD Senior Scientist will provide strategic analytical leadership as an Attribute Sciences team lead to teams developing commercializable manufacturing processes and collaborate with Drug Substance and Drug Product colleagues.

Requirements

• Doctorate degree OR Master’s degree and 2 years of directly related life science experience OR Bachelor’s degree and 4 years of directly related life science experience OR Associate’s degree and 8 years of directly related life science experience OR High school diploma / GED and 10 years of directly related life science experience

Nice To Haves

• Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting
• 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
• 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

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

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees