Process Development Sr Scientist

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us!

Process Development Sr. Scientist

Live

What you will do

Lets do this. Lets change the world! In this pivotal role within Amgens 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 (synthetics, 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.

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.

Win

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

• Doctorate degree and 2 years of scientific experience OR
• Masters degree and 5 years of scientific experience OR
• Bachelors degree and 7 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 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
• 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.

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.