Associate Director Process Development

Associate Director, Commercial Drug Products & Life Cycle Management

Let’s do this. Let’s change the world. In this vital role you will be part of Amgen’s Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high‑quality CMC sections, and ensuring supply of commercial products.

Drug Product Team Leaders (DPTLs) play a central role in the process by serving as single point of accountability for individual drug product programs and leading a technical team responsible for delivering drug product process transfers, process optimization, and timely closure of non‑conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking an Associate Director to lead commercial drug product programs as DPTL and to support advancing the commercial drug product programs in our portfolio.

• Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations.
• Lead a team of scientists focused on late‑stage drug product process development and tech transfer and coach staff with emphasis on people‑centered leadership.
• Provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non‑conformance investigations and process changes/improvements.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Participate and lead global cross‑functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and responses to regulatory questions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
• Ability to travel domestically and internationally up to 10% of the time.

The professional we seek is a leader with the following qualifications.

• Doctorate degree and 3 years of experience in engineering or science
• Masters degree and 7 years of experience in engineering or science
• Bachelors degree and 9 years of experience in engineering or science
• Associate’s degree and 12 years of experience in engineering or science
• High school diploma / GED and 14 years of experience in engineering or science
• In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.

• 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
• Demonstrated 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
• Experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, and supporting validation activities and PAIs at commercial sites
• Understanding of…