200+ applicants
Amgen · 6 days ago
Process Development Senior Principal Scientist - CMC Team Lead
Cambridge, MA
Full-time
Hybrid
Senior Level
7+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesBiotechnologyHealth Care
Insider Connection @Amgen
Responsibilities
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.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor’s degree and 8 years of scientific / pharmaceutical experience OR
Master’s degree and 6 years scientific / pharmaceutical experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of scientific / pharmaceutical experience
Preferred
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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10,001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (349)
2022 (523)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-24IPO· nasdaq:AMGN
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Judy Brown
SVP Corporate Affairs
Recent News
2024-06-05
MarketScreener
2024-06-05
Company data provided by crunchbase
