Director Process Development

Amgen is committed to unlocking the potential of biology for patients suffering from serious by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the illnesses complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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.

Do you want to help craft the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients lives?

Amgen is seeking a Director of Process Development at its Rhode Island Drug Substance manufacturing site. In this role the candidate will lead the Drug Substance Process Engineering function responsible for technical oversight of commercial drug substance operations within a high mix, multiproduct manufacturing facility. The successful candidate will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality. This leader will ensure that process engineering deliverables including new process introduction; implementation of new technologies; Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and executed. They will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process, technology and capacity improvement opportunities. The Director ensures groups outputs are safe, compliant, and aligned with plant performance goals.

Responsibilities:

• Support process scale-up and technology transfer to production facilities. Partners closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
• Lead a high performing team and committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
• Provide strategic leadership required to drive year over year productivity through yield and capacity projects on site.
• Lead multi-functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives.
• Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
• Engage Play a critical role in engaging with the manufacturing and process development network to assess technology and to , improve facility capacity and capability, and ensure lessons learned are applied across the network.

Basic Qualifications:

Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience

OR

Masters degree and 8 years of Process Development, Engineering or Manufacturing experience

OR

Bachelors degree and 10 years of Process Development, Engineering or Manufacturing experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• MS degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field
• 10+ years of experience in pharmaceutical/biopharmaceutical process development or process support in a current Good Manufacturing Practices (cGMP) environment and global regulatory expectations
• Proven ability in providing scientific and engineering expertise to multi-functional teams in manufacturing, quality and supply chain to advance complex projects to completion and to interface on technical problem resolution
• Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management
• Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design, PPQ, Continued Process Verification (CPV)
• Understanding of quality attributes of small molecules and protein products and analytical methods for determination of these attributes
• Demonstrated skills in leadership, negotiation and managing customer expectations

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.

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.

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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.

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.