Scientist

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
• Masters degree and 4 years of experience OR
• Bachelors degree and 6 years of experience
  

Preferred Qualifications

• Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline or
• Masters degree and 4 years of experience contributing to and/or participating in scientific projectteamsor
• Bachelors degree and 6 years of experience contributing to and/or participating in scientific projectteamsor
• Associatesdegree and 8 years of experience contributing to and/or participating in scientific projectteams
• Expertise in bioreactor and/or purification process development
• Extensive experience in development and/or support of bio-manufacturing processes, including process scale-upand 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

Join Us

If 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.