Associate Director, Process Development

About the role

Amgen is looking for an Associate Director to lead commercial drug product programs as a Drug Product Team Leader (DPTL) and head a scientific team supporting its portfolio. The role sits in the Process Development organization's Drug Product Technologies unit, which aims to deliver robust drug product manufacturing processes, high-quality CMC sections and reliable supply of commercial products. It involves leading drug product process transfers, optimization, troubleshooting, non-conformance investigations and change controls.

Key responsibilities

• Lead Drug Product Commercialization Teams in planning, designing, running and documenting laboratory studies for drug product design, formulation and process development of parenteral and/or oral solid dosage forms.
• Lead a team of scientists focused on late-stage process development and tech transfer, coaching staff with a people-centered approach.
• Support clinical and commercial fill/finish operations through process capability analysis, troubleshooting, root cause analysis and product impact assessments.
• Drive continuous improvement using technological innovation and first principles in process engineering.
• Participate in and lead global cross-functional teams in a matrixed environment.
• Author and review guidelines, protocols, reports, regulatory submissions and responses to regulatory questions.
• Deliver progress reports and presentations to management.
• Use advanced IS systems to speed data availability, analyze large data sets and apply statistical analysis.

Required profile

• Basic qualification: doctorate with 3 years, master's with 7 years, bachelor's with 9 years, associate's with 12 years, or high school diploma with 14 years of engineering or science experience.
• At least 3 years of direct people management and/or leadership experience leading teams, projects or programs.
• Preferred: PhD in biotechnology, pharmaceutical sciences, chemical engineering or a related field, 8+ years of pharmaceutical development and management experience, and 8+ years of formulation and process development in a major biopharma organization.
• Hands-on experience with end-to-end development of liquid, lyophilized and/or oral solid dosage products, process transfers, control strategies, MAs, validation support and PAIs at commercial sites.
• Knowledge of protein stability, single-use manufacturing, aseptic processing, cGMP and ICH guidelines, and experience with SPC and experimental design.

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico).
• Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, 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.