Job Abstract

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development 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 (large molecule, siRNA, virus, etc.). 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.

• Participate in 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 products.

• 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.

• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and solve technical challenges.

• Participate in 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.

• Effectively and consistently communicate with management, cross-functional partners and relevant collaborators on progress towards achievements and forthcoming program needs.

• Actively apply 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.

• Doctorate degree OR

• Master’s degree and 2 years of scientific experience OR

• Bachelor’s degree and 4 years of scientific experience

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area

• Experience in pharmaceutical development and manufacturing

• 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 unit operation for both parenteral (i.e. filling, filtration, mixing, etc.) and oral solid dosage manufacturing (i.e. milling, granulation, blending, etc), specific scale-down model development, characterization, and scale-up

• 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

• Critical thinking, strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas.

• Ability to learn and rapidly react in an environment with dynamic information.

• Good organizational skills with strong attention to detail

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range