Process Development Sr Principal Scientist

Amgen • Thousand Oaks, CA

1d

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Process Development Sr Principal Scientist What you will do Let’s do this. Let’s change the world. In this vital role within Amgen’s Commercial Drug Product Technologies group, you will be responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities. You will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization and life-cycle of the products. 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 biologic drug product presentations. 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 inspire change, efficiency, and cultivate 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, using historical information, analyzing large data sets, and statistical analysis. Ability to travel domestically and internationally up to 10% of the time.

Requirements

• Doctorate degree PhD OR PharmD OR MD and 3 years of Scientific experience OR Master’s degree and 6 years of Scientific experience OR Bachelor’s degree and 8 years of Scientific experience

Nice To Haves

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area
• 5+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
• Knowledge of/hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
• Knowledge and awareness of the regulations governing combination product development
• Experience with parenteral biologics (i.e. filling, filtration, mixing, etc.) process characterization, scale-up, and commercial manufacturing
• 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 long-term stability
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre-approval inspection/audits
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas.
• Previous scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important.
• Ability to learn and rapidly react in an environment with dynamic information.

Responsibilities

• 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 biologic drug product presentations.
• 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 inspire change, efficiency, and cultivate 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, using historical information, analyzing large data sets, and statistical analysis.

Benefits

• 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, and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree