Associate Director Process Development
Amgen
22 days ago
Remote friendly (Thousand Oaks, CA)
United States
Operations
Associate Director, Commercial Drug Products & Life Cycle Management
What You Will Do
- Serve as single point of accountability for drug product programs: formulation, aseptic process design/validation, combination product lifecycle, process improvements, life cycle changes, regulatory submissions, and annual product reviews.
- Lead technical teams delivering drug product process transfers, optimization, troubleshooting, and closure of non-conformance investigations and change control assessments to ensure commercial supply.
- Lead drug product commercialization teams: plan, execute, and document lab studies for design, formulation, and process development for parenteral and/or oral solid dosage presentations.
- Support fill/finish operations with capability analysis, troubleshooting, RCA, and product impact assessments.
- Drive continuous improvement via technological innovation and first-principles process engineering.
- Author/review technical protocols/reports, product impact assessments, and regulatory submissions; respond to regulatory questions.
- Use advanced IS systems; deliver progress updates/presentations; participate in global cross-functional, matrixed teams.
- Travel up to 10%.
What We Expect Of You
Basic Qualifications
- Doctorate + 3 yrs engineering/science OR Master’s + 7 yrs OR Bachelor’s + 9 yrs OR Associate’s + 12 yrs OR HS/GED + 14 yrs; plus minimum 3 years directly managing people and/or leadership managing teams/projects/programs/resources.
Preferred Qualifications
- PhD in related fields; 8+ yrs pharma development/management; deep formulation/process development; drug product commercialization/combination products; experience with transfers, control strategy, MAs, regulatory responses, validation/PAIs; protein stability knowledge; single-use equipment; aseptic/cGMP/ICH; SPC and DOE; strong cross-functional communication.
What You Can Expect Of Us (Benefits)
- Comprehensive benefits incl. Retirement/Savings, medical/dental/vision, life/disability, flexible spending; bonus/incentives; stock-based long-term incentives; time-off; flexible work where possible.
Application Instructions
- Apply at careers.amgen.com; no application deadline; continues until sufficient applications or selection.
What You Will Do
- Serve as single point of accountability for drug product programs: formulation, aseptic process design/validation, combination product lifecycle, process improvements, life cycle changes, regulatory submissions, and annual product reviews.
- Lead technical teams delivering drug product process transfers, optimization, troubleshooting, and closure of non-conformance investigations and change control assessments to ensure commercial supply.
- Lead drug product commercialization teams: plan, execute, and document lab studies for design, formulation, and process development for parenteral and/or oral solid dosage presentations.
- Support fill/finish operations with capability analysis, troubleshooting, RCA, and product impact assessments.
- Drive continuous improvement via technological innovation and first-principles process engineering.
- Author/review technical protocols/reports, product impact assessments, and regulatory submissions; respond to regulatory questions.
- Use advanced IS systems; deliver progress updates/presentations; participate in global cross-functional, matrixed teams.
- Travel up to 10%.
What We Expect Of You
Basic Qualifications
- Doctorate + 3 yrs engineering/science OR Master’s + 7 yrs OR Bachelor’s + 9 yrs OR Associate’s + 12 yrs OR HS/GED + 14 yrs; plus minimum 3 years directly managing people and/or leadership managing teams/projects/programs/resources.
Preferred Qualifications
- PhD in related fields; 8+ yrs pharma development/management; deep formulation/process development; drug product commercialization/combination products; experience with transfers, control strategy, MAs, regulatory responses, validation/PAIs; protein stability knowledge; single-use equipment; aseptic/cGMP/ICH; SPC and DOE; strong cross-functional communication.
What You Can Expect Of Us (Benefits)
- Comprehensive benefits incl. Retirement/Savings, medical/dental/vision, life/disability, flexible spending; bonus/incentives; stock-based long-term incentives; time-off; flexible work where possible.
Application Instructions
- Apply at careers.amgen.com; no application deadline; continues until sufficient applications or selection.