Associate Director, Process Development

Amgen

Associate Director leading commercial drug product programs in Amgen's Process Development organization. Driving innovation and overseeing technical aspects of drug product development.

Posted 5/16/2026full-timeThousand Oaks • California, Massachusetts • 🇺🇸 United StatesSenior💰 $164,022 - $221,912 per yearWebsite

About the role

Key responsibilities & impact

Part of Amgen’s Process Development organization, Drug Product Technologies unit
Deliver superior, robust drug product manufacturing processes, high-quality CMC sections
Serve as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation
lead a scientific team advancing commercial drug product programs
Responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development
Drive continuous improvement in the drug product development process through technological innovation
Participate and lead global cross-functional teams to influence efficiency and foster strong relationships
Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
Deliver progress reports and presentations to management.

Requirements

What you’ll need

Doctorate degree and 3 years of experience in engineering or science OR Masters degree and 7 years of experience in engineering or science OR Bachelors degree and 9 years of experience in engineering or science OR Associate’s degree and 12 years of experience in engineering or science OR High school diploma / GED and 14 years of experience in engineering or science
Minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
PhD from an accredited college or university in Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
8+ years of pharmaceutical development and management experience
8+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
Knowledge of drug product commercialization and integrated combination product development with hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
Experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
Strong knowledge about developing processes with single-use manufacturing equipment
Aseptic processing experience and familiarity with cGMPs, ICH guidelines
Strong problem solving and effective cross-functional communication skills.

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

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Hard Skills & Tools

drug product manufacturing processesformulationaseptic drug product process designprocess developmentregulatory submissionsprocess transferscontrol strategysingle-use manufacturing equipmentcGMPICH guidelines

Soft Skills

leadershipteam managementproblem solvingcross-functional communicationrelationship buildingplanningexecutingdocumentingcontinuous improvementtechnical writing

Certifications

PhD in BiotechnologyPhD in Pharmaceutical SciencesPhD in Pharmaceutical ChemistryPhD in Chemical EngineeringPhD in Biomedical Engineering