Process Development Senior Principal Scientist
Amgen
5 months ago
On-site
Cambridge, MA
Operations
Process Development Senior Principal Scientist
What You Will Do
- Manage an integrated group of cell culture and purification scientists.
- Responsible for development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs.
- Lead a group to apply platform approaches to rapidly solve development challenges and build robust processes with efficient experimentation (work across antibodies, biosimilars, bispecifics, and other protein-based modalities).
- Develop and recruit strong and diverse teams; support staff career development.
- Lead matrix cross-functional teams delivering robust drug substance commercialization data packages, including authoring CMC sections of regulatory documents, interacting with regulatory agencies, supporting technology transfers, and working with CDMOs/CMOs.
- Ideate, develop, and deploy differentiating technologies; establish a culture of innovation.
- Expand external eminence and represent Amgen in the external scientific community.
Basic Qualifications
- Bachelor’s degree and 8 years of scientific experience, OR
- Master’s degree and 6 years of scientific experience, OR
- Doctorate (PhD/PharmD/MD [and relevant post-doc where applicable]) and 3 years of scientific experience.
Preferred Qualifications
- Doctorate in Chemical Engineering/Biochemical Engineering or relevant sciences with 4+ years’ experience, OR Bachelor’s/Master’s with 10+ years of relevant industry experience.
- Proven problem-solving/troubleshooting in process development; ability to independently identify, develop, and implement scientific solutions.
- Experience with drug substance commercialization activities (including regulatory agency interactions); familiarity with DOE and statistical analysis.
- Strong bioprocess development expertise (cell culture, harvest, purification).
- Track record of innovation; sustained peer-reviewed publications and conference presentations.
- Excellent interpersonal/organizational skills; strong verbal and scientific writing skills.
- Leadership experience with progressively increased scope; ability to inspire and lead scientists to deliver complex objectives within timelines.
- Success working in diverse cross-functional environments; proven mentoring/ability to help staff reach potential.
Benefits
- Total Rewards Plan (based on eligibility), including comprehensive benefits: retirement & savings plan, group medical/dental/vision, life & disability insurance, flexible spending accounts; discretionary annual bonus (or field sales incentive); stock-based long-term incentives; award-winning time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com.
What You Will Do
- Manage an integrated group of cell culture and purification scientists.
- Responsible for development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs.
- Lead a group to apply platform approaches to rapidly solve development challenges and build robust processes with efficient experimentation (work across antibodies, biosimilars, bispecifics, and other protein-based modalities).
- Develop and recruit strong and diverse teams; support staff career development.
- Lead matrix cross-functional teams delivering robust drug substance commercialization data packages, including authoring CMC sections of regulatory documents, interacting with regulatory agencies, supporting technology transfers, and working with CDMOs/CMOs.
- Ideate, develop, and deploy differentiating technologies; establish a culture of innovation.
- Expand external eminence and represent Amgen in the external scientific community.
Basic Qualifications
- Bachelor’s degree and 8 years of scientific experience, OR
- Master’s degree and 6 years of scientific experience, OR
- Doctorate (PhD/PharmD/MD [and relevant post-doc where applicable]) and 3 years of scientific experience.
Preferred Qualifications
- Doctorate in Chemical Engineering/Biochemical Engineering or relevant sciences with 4+ years’ experience, OR Bachelor’s/Master’s with 10+ years of relevant industry experience.
- Proven problem-solving/troubleshooting in process development; ability to independently identify, develop, and implement scientific solutions.
- Experience with drug substance commercialization activities (including regulatory agency interactions); familiarity with DOE and statistical analysis.
- Strong bioprocess development expertise (cell culture, harvest, purification).
- Track record of innovation; sustained peer-reviewed publications and conference presentations.
- Excellent interpersonal/organizational skills; strong verbal and scientific writing skills.
- Leadership experience with progressively increased scope; ability to inspire and lead scientists to deliver complex objectives within timelines.
- Success working in diverse cross-functional environments; proven mentoring/ability to help staff reach potential.
Benefits
- Total Rewards Plan (based on eligibility), including comprehensive benefits: retirement & savings plan, group medical/dental/vision, life & disability insurance, flexible spending accounts; discretionary annual bonus (or field sales incentive); stock-based long-term incentives; award-winning time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com.