Process Development Senior Principal Scientist
Amgen
- Cambridge, MA
- $157,242-182,988 per year
- Permanent
- Full-time
- Lead a team of scientists focused on method development and molecule characterization for biologics in late-stage development serving as a mentor, sponsor, and coach with emphasis on people-centered leadership.
- Serve as the Attribute Sciences team lead on a cross-functional product development team for a biologic in late-stage development with accountability of key decisions, strategies, and deliverables within the analytical sciences space.
- Author chemistry, manufacturing and controls (CMC) sections in regulatory files, lead the preparation of responses to analytical related questions from health authorities, and support pre-approval inspections.
- Establish strong partnerships with leaders from multiple functions across Amgen to achieve program deliverables.
- Expert knowledge in the analysis of protein-based therapies with advanced techniques such as capillary electrophoresis, liquid chromatography, and mass spectrometry.
- Solid understanding of cGMP / ICH regulations and compendial guidelines with the ability to apply them to analytical development.
- Ability to develop and implement integrated control strategies for critical quality attributes of biologic therapeutics.
- Develop and document standard operating procedures, protocols and reports.
- Develop novel process or approaches to tackle complex problems.
- Bachelor’s degree and 7 years of scientific / pharmaceutical experience OR
- Master’s degree and 5 years of scientific / pharmaceutical experience OR
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of scientific / pharmaceutical experience
- Degree in analytical chemistry, physical chemistry, biochemistry, pharmaceutical sciences, or related discipline.
- Strong people-leadership skills and experience with leading a team of direct reports.
- Excellent laboratory skills with 7+ years of laboratory research or experience in industry. laboratories supporting analysis and characterization of protein therapies.
- Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE-SDS, cIEF / icIEF, HIC, SEC, IEX, RP, HILIC, MS, etc.
- Expertise with handling, troubleshooting, and maintaining CE and LC instruments.
- Expertise using CE and LC operation and data analysis software.
- Experience with data processing and statistical analysis software tools.
- Ability to independently prioritize, schedule, and lead multiple tasks to meet results.
- Proven ability to lead complex projects or work packages.
- Ability to work in a matrix team environment and collaborate effectively.
- Excellent written and oral communication skills.
- Experience with use of electronic notebooks.
- Firsthand experience with method qualifications and transfers.
- Skilled in phase appropriate GMP compliance and documentation.