Process Development Sr Scientist - Attribute Sciences

About the role

Amgen's Attribute Sciences (AS) team within Process Development defines the quality characteristics of its therapies and optimizes analytical tools to guide development. The Pivotal PD organization develops and commercializes robust manufacturing processes for synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers and live oncolytic viruses. This Senior Scientist role, based in the Thousand Oaks, CA office, acts as an AS team lead for a pivotal clinical process development program, providing analytical leadership to teams building commercializable manufacturing processes and working 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.
• Lead the analytical work for a pivotal clinical process development program.
• Define the analytical target profile (ATP) for product quality monitoring methods and oversee their development, qualification, remediation and transfer to Quality Control.
• Manage activities at contract manufacturing and testing sites.
• Write technical reports and analytical CMC sections in regulatory documents and answer product quality questions from health authorities.
• Support product characterization for process comparability studies, regulatory filings and reference standard qualification.
• Evaluate Amgen's platform and analytical technologies and help define strategies to improve the Attribute Sciences department.

Required profile

• Basic qualifications: doctorate; or master's degree with 2 years of directly related life science experience; or bachelor's degree with 4 years; or associate's degree with 8 years; or high school diploma/GED with 10 years of directly related life science experience.
• Preferred: doctorate with 5-7+ years in analytical chemistry, biochemistry or equivalent; experience in a multidisciplinary biopharmaceutical team.
• Strong problem-solving skills, solid leadership and decision-making skills, and ability to work across time zones.

Required skills

• Analytical method development for biologics such as monoclonal antibodies and multispecifics.
• HPLC and CE methods (reversed-phase, size-exclusion, ion-exchange, affinity HPLC, CE-SDS, cIEF).
• Knowledge of regulatory requirements and experience with regulatory filings.
• Understanding of product quality attributes of therapeutic proteins (glycosylation, deamidation, oxidation, partial reduction) and GLP/GMP.
• Technical writing and cross-functional leadership of CMC and non-clinical teams.

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.