Associate Director Process Development

About this role

Career Category Scientific Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Director, Commercial Drug Products & Life Cycle Management What you will do 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 this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, 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 lead a scientific team that supports 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, as needed, 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 developing 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.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: 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 And 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 the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

Preferred Qualifications: • PhD from an accredited college or university in one of the following areas 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 in various presentations

• Demonstrated 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, specifically, the impact of freezing and drying to short- and

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