Career Category

Process Development

Job Description

Amgen is seeking a Process Development Scientist within our Pre-pivotal Bioprocess Development (BD) organization based at our Thousand Oaks, California campus.  Pre-pivotal BD is responsible for the development, scale-up, and transfer of both upstream and downstream processes for early clinical manufacturing of therapeutic molecules. The programs develop a wide range of biological molecules including mAbs, BiTEs, bispecifics, conjugations, and other novel modalities ranging from early molecule assessments with Research to IND enabling GMP manufacturing supplies for clinical studies.

The primary focus of this position will be upstream bioreactor and downstream purification development. The drug substance development deliverables for this role include molecule assessments, clone selections, First-In-Human (FIH) bioreactor and purification process development, and tech transfers to clinical manufacturing. In addition, the role will entail the development and implementation of new technologies, authoring regulatory CMC documents, and evaluating process capabilities for viral clearance.

Key Responsibilities

• Leading a team of cell culture and purification scientists that develop processes for clinical manufacturing
• Applying technical and platform knowledge to design studies for the development of purification processes
• Serving in cross-functional or cross-site roles
• Contributing to the scientific literature and conferences, gaining recognition as a subject-matter expert in both internal and external purification communities
• Investigating and implementing relevant new technologies
• Interfacing with regulatory agencies in support of CMC filings
• Analyzing and presenting data internally for governance and technical meetings
• Contributing to viral clearance process evaluations and company strategies

Qualifications

• Doctorate degree  OR
• Master’s degree and 4 years of experience OR
• Bachelor’s degree and 6 years of experience
   

Preferred Qualifications

• Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline or
• Master’s degree and 4 years of experience contributing to and/or participating in scientific project teams or
• Bachelor’s degree and 6 years of experience contributing to and/or participating in scientific project teams or
• Associate’s degree and 8 years of experience contributing to and/or participating in scientific project teams 
• Expertise in bioreactor and/or purification process development
• Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production 
• Track record of innovation and implementation of new technologies 
• Experience in authoring IND sections and interaction with regulatory agencies 
• Experience in viral clearance evaluation per ICH Q5A guidelines

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