Process Development Sr Scientist (Attribute Sciences)

About the role

Amgen is hiring a Process Development Senior Scientist in its Attribute Sciences (AS) department, located in the Thousand Oaks, CA office. Attribute Sciences defines the quality characteristics of Amgen's therapies and optimizes analytical tools to guide development. The role leads analytical work for a pivotal clinical process development program and works closely with Drug Substance and Drug Product colleagues.

Key responsibilities

• Supervise and provide technical support for a team giving analytical support to late-stage product development.
• Act as Attribute Sciences team lead for a pivotal clinical process development program, owning all analytical work for the program.
• Define the analytical target profile (ATP) for methods monitoring product quality, and oversee development, qualification, remediation and transfer of analytical methods to Quality Control.
• Manage activities at contract manufacturing and testing sites.
• Write technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents, and answer analytical and product quality questions from health authorities.
• Support product characterization for process comparability studies, regulatory filings, regulatory questions and reference standard qualification.
• Evaluate Amgen's platform and analytical technologies and help define strategies to improve the Attribute Sciences department.

Required profile

• PhD, PharmD or MD (with relevant post-doc where applicable), or Master's degree with 3 years of scientific experience, or Bachelor's degree with 5 years of scientific experience.
• Preferred: doctorate with 5 years in analytical chemistry, biochemistry or equivalent, and experience in a multidisciplinary biopharmaceutical team.
• Experience in technical transfer to external contract organizations and excellent technical writing skills.

Required skills

• Analytical method development for biologics such as monoclonal antibodies and multispecifics.
• Mass spectrometry (intact mass and peptide mapping) and HPLC and CE methods (reversed-phase, size-exclusion, ion-exchange, affinity, CE-SDS, cIEF).
• Knowledge of regulatory requirements and GLP/GMP, and experience with regulatory filings.
• Familiarity with product quality attributes of therapeutic proteins (glycosylation, deamidation, oxidation, partial reduction) and their characterization tools.
• Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing.

What we offer

• Base salary with a total rewards plan depending on eligibility.
• Retirement and savings plan with company contributions, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
• Flexible work models where possible.