Executive Director Process Development- Pivotal Drug Substance
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.
EXECUTIVE DIRECTOR, PROCESS DEVELOPMENT PIVOTAL DRUG SUBSTANCE
What you will do
Lets do this. Lets change the world. In this vital role you will Lead Amgens pivotal phase drug substance process development organization. Accountable for leading teams that design, develop, and characterize commercial processes for all biologics andhas a cross-site team. You will also be accountable for reviews and defendable strategies for filings of commercial processes that get executed across internal and external commercial manufacturing sites. Additionally, this individual will:
- Oversee a team responsible for leading commercial process design and providing support for commercial products
- Be responsible for all commercial Drug Substance processes CMC authorship, reviews, and approvals
- Own networkresponsibilitiesthatinclude Life Cycle Managementsupport
- Own the Drug Substance Platformbusinessprocessand excellence
- Provide oversight and leadership of innovation and manufacturing technologyadvancementsand implementation in our network
- Drive networkalignmentofprocess design and characterization practicesandinitiatives
- Leverage data science to process prior knowledge within Drug Substance Technologies
- Identify and implement innovative solutions and technologies to drive continuous improvement in drug substances operations.
- Manage high performing team and provide innovative strategies to maximize team engagement and ensure team reaches full potential.
- Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
- Serve as member of the Drug Substance Technology (DST) leadership team and extended Process Development leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The executive-level professional we seek is a leader with these qualifications.
- PhD in Biochemical or Chemical Engineering
- 10+ years of experience in biopharmaceutical process development or commercial cell culture process support in a cGMP environment
- Strong technical understanding of at least one area of drug substance bioprocessing upstream or downstream and able to direct aspects of area where one is not a subject matter expert
- Drive differentiating innovation across drug substance to reduce cost of sales and sustain industry leadership
- Experienced in late stage regulatory strategies and balance risk/reward discussions with regulators
- Ability to view all deviations through the lens of PAI/regulatory discovery
- Experience leading large, multi-site organization
- Demonstrated ability in providing bioprocess development expertise to cross-functional teams to advance complex projects to completion
- Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management
- Understanding of quality attributes of protein products and analytical methods for determination of these attributes
- Demonstrated skills in negotiation, conflict resolution and managing customer expectations
- Direct experience supporting commercial, biopharmaceutical process development
- Experience of cell culture and downstream process development, bioreactor design and control, and harvest and purification technologies using centrifugation and filtration as well as industrial scale chromatography and filtration operations
- Thorough understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continuous Process Validation (CPV)
- Interfacing with manufacturing, quality and supply chain on technical problem resolution
- Strong understanding of cGMP and global regulatory expectations
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.