Director of Cellular Sciences
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Director, Cellular Sciences
What you will do
Lets do this. Lets change the world. In this vital role you will lead Amgens Cellular Sciences organization. You will be accountable for serving every patient every time by ensuring our adventitious agent monitoring and control strategy is reliable and robust to ensure high quality product for patients. Specifically, the successful candidate will:
- Provide technical leadership of adventitious agent monitoring and control strategy
- Oversee viral clearance, mycoplasma testing, method troubleshooting
- Advance microbiological assays and control strategies
- Conduct adventitious agent safety evaluation and assess starting materials and excipients of biological origin
- Support contamination risk mitigation and associated investigations
- Manage critical reagent production, testing, and inventory
- Support Quality and Regulatory interactions
- Manage a high performing team
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The director level professional we seek is a leader with these qualifications.
- Doctorate Degree & 4 years of Process Development or Manufacturing Science Technologies experience OR
- Masters Degree & 8 years of Process Development or Manufacturing Science Technologies experience OR
- Bachelors Degree & 10 years of Process Development or Manufacturing Science Technologies experience AND
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Ph.D. or equivalent in cell biology, biochemistry, virology, molecular biology, microbiology or related major and 10+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams
- Direct experience with adventitious agent monitoring and control for biologics manufacturing
- Understanding and applied knowledge of regulatory requirements for the pharmaceutical industry (e.g. FDA, ICH, and USP guidelines)
- Knowledge of viral clearance, microbial control, and aseptic manufacturing
- Knowledge of compendial microbiological tests and novel rapid testing methods
- Direct experience with regulatory filings and deep knowledge of regulatory requirements
What you can expect of us
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.
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
Join UsIf 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.