Alkermes · 1 month ago
Principal Scientist, Analytical Development
Greater Boston
Full-time
Onsite
Lead/Staff
$180K/yr - $196K/yr
8+ years expAlkermes is a fully-integrated, global biopharmaceutical company dedicated to developing medicines for complex psychiatric and neurological disorders. The Principal Scientist in Analytical Development will provide technical leadership and subject matter expertise in small molecule analytical methodologies, guiding drug substance and product characterization from pre-clinical research through commercialization.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as the primary Analytical Development representative on CMC teams, translate program objectives into phase‑appropriate analytical strategies, plans, and timelines
Provide strategic CDMO oversight for analytical activities , which may include product characterization, GMP in process, release and stability testing, laboratory investigations, and method optimization
Provide subject matter expertise in analytical development methodologies, guide and drive analytical method development, method implementation, product characterization and analytical control strategy development for pre-clinical and clinical stage development programs
Design, execute, and analyze analytical method validation and transfer activities suitable for progressive stages of small molecule pharmaceutical development that are in compliance with ICH and FDA guidance
Work closely with colleagues across Pharmaceutical Development and Research organizations to best leverage internal and/or external capabilities, equipment and instrumentation to identify and document critical factors to impact method performance
Develop, review, and approve analytical source documents, and author and review drug product and drug substance analytical sections for regulatory submissions
Present technical data to cross functional teams and senior management as an analytical expert, and effectively communicate critical analytical issues and solutions
Identify and advocate new and emerging technology opportunities for analytical and physical characterization
Train and mentor more junior Analytical Development staff, as needed
Perform other duties as assigned
Qualification
Required
PhD with 8 years or MS with 15 years with related experience in analytical chemistry, organic chemistry, or biochemistry
Preferred
Broad understanding of the drug development process and more precisely the role and impact of analytical development within this process
Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
Demonstrated experience representing Analytical Development on CMC teams for both DS and DP programs, driving analytical strategy and control strategies across phases
Proven track record of CDMO oversight/governance for analytical activities (method lifecycle, characterization, GMP testing, investigations), with delivery against scope, schedule, and quality
Expertise and demonstrated experience in small molecule analytical method development, validation and transfer
Technical problem-solving ability utilizing current research and technologies
Demonstrated collaborative leadership, strong interpersonal skills, and excellent verbal and written communication skills
Subject matter proficiency across a range of spectroscopic, titration, dissolution and separation-based analytical methodologies and laboratory software systems
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities
Previous experience with applying DoE in method development is preferred
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-09
2026-01-06
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