Process Development Scientist - Viral Clearance Assessment

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Process Development Scientist-Viral Clearance Studies

Live

What you will do

Lets do this. Lets change the world. In this vital role you will ensure viral safety of biotechnology in Amgen.

• Ensuring Viral Safety of biotechnology derived therapeutics by performing Viral Clearance Assessments for clinical and commercial programs.
• Design the viral clearance study in accordance with guidelines (e.g. EMEA and ICH Q5A). Authoring of protocols and reports and interaction with regulatory agencies are required.
• Design and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards.
• Work independently and in team to review and trend data, generating trending reports, as necessary.
• Technical Development Design of Experiment (DOE) to support continuous improvement for downstream processes
• Support deviations, investigations, and analytical method performance trending and root cause analysis.
• Effectively interface with cross functional teams, including but not limited to Drug Substance Technology, Virology and Molecular Biology, Quality Assurance, and Regulatory to align on activities in all developmental stages and compliance.
• Assist in advancing Amgens acumen on GMP compliance and current regulatory trends and expectation.
• investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
• Guide and mentor junior scientists on viral clearance studies.
• Safely operate laboratory equipment in accordance with established practices.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process development professional we seek is an independent individual with these minimum qualifications.

• Doctorate degree or
• Master's degree and 4 years of regulated industry experience or
• Bachelor's degree with 6 years of regulated industry experience

Preferred Qualifications:

• In-depth knowledge of AKTA Avant and related purification systems
• In-depth understanding of cell based viral assays
• Familiar with regulatory filings, including IND, BLA
• Experience with one or more of the methods and/or assays such as: Cell based viral assays (TCID50), viral contamination assays, mycoplasma testing, qPCR, gene sequencing.
• Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.
• Ability to gown for and work in BSL-2 laboratory.
• Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
• Ability to use routine laboratory equipment including, but not limited to, balances, centrifuges, microscopes, etc.
• Ability to work well under pressure, multi-task, and have good organizational and communication skills.

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

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.

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.