Process Development Principal Scientist

Career Category

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.

Process Development Principal Scientist

What you will do

Let’s do this! Let’s change the world!

In this pivotal 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.

Role 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 both parenteral and oral solid dosage 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative leader with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 7 years of Scientific experience OR

• Master’s degree and 5 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience

Preferred Qualifications:

• 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

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