Senior Associate Scientist
Amgen is seeking a Process Development Senior Associate 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 downstream purification development. The drug substance development deliverables for this role include molecule assessments, clone selections, First-In-Human (FIH) purification process development, and tech transfers to clinical manufacturing. In addition, the role will entail the development and implementation of new purification technologies, authoring regulatory CMC documents, and evaluating process capabilities for viral clearance.
- Leading a team of purification scientists to 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
- 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
- Masters degree or higher with a minimum of 5 years of experience contributing to and/or participating in purification science.
- Expertise and experience in purification process development
- Experience in development and/or support of bio-manufacturing processes, including process scale-upand GMP production
- Experience in authoring IND sections and interaction with regulatory agencies
- Experience in viral clearance evaluation per ICH Q5A guidelines
- Doctorate degree OR
- Masters degree and 4 years of experience OR
- Bachelors degree and 6 years of experience
- Understands purification techniques for biological molecules (e.g. chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation, etc.)
- Capability to independently author technical reports, regulatory filings, patents, and peer reviewed publications
- Capable of conveying information and recommendations on scientific issues to senior management
- Serves as a technical authority and keeps current in relevant literature and related technology
- Works cross-functionally to author CMC documents in support of Amgensregulatory filings
- Develops processes to deliver multi-kilogram quantities of drug substance to cGMP operation
- Leads deliveries of drug substance in a cGMPmanufacturing environment in both internal and external capacity
- Ensures that safe laboratory practices are followed
- Provides mentoring and expertise to less-experienced staff
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Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.