Principal Scientist, Clinical & Nonclinical Bioanalysis

Company Name: Alkermes

Description of Duties

We are seeking a highly motivated candidate with hands-on experience in developing small molecule and biomarker assays and sample analysis using LC-MS/MS. The successful candidate will support Preclinical and Clinical programs with in-house and CRO resources and represent on the bioanalytical team.

• Responsible for developing and implementing the R&D bioanalytical strategy for Alkermes’ R&D portfolio ensuring that bioanalytical support is completed in a timely manner, meets current scientific and regulatory standards, and adequately supports candidate nomination.
• Responsible for providing scientific and technical oversight to the bioanalytical vendor during method development, transfer, qualification/validation, and sample analysis.
• Responsible for providing strategic input and scientific expertise to program teams on all issues relevant to bioanalysis. Manage and resolve any problems or issues while keeping team and management informed of critical issues in a timely manner.
• Responsible for ensuring reports are complete and accurate and meet regulatory filing requirements. Provides input to appropriate sections of study reports.
• Responsible for preparing and/or providing input on regulatory documents including: CTA, IND, NDA.
• Perform analysis of biological samples to support drug discovery & nonclinical / clinical development for potential candidates using LC-MS/MS assays and oversight method development, qualification/validation, and sample analysis at CRO.

The Principal Scientist, Bioanalysis is expected to advise teams and management continuously and proactively on the development and optimization of bioanalytical technologies, strategies and regulatory requirements to improve the quality, productivity, and compliance of the function. Candidates will be partnering with Discovery, DMPK, Nonclinical Safety Evaluation and Clinical Pharmacology colleagues to identify and manage external vendor to support sample analysis.

The candidate will also be required to stay current with the latest in technological and regulatory advances in the bioanalytical realm.

Basic Requirements

• MS with 15+ years of experience or Ph.D. with 8+ years, in the development of LC-MS/MS for the quantitation of small molecules.
• Prior experience with laboratory and vendor management is required.

Preferred Requirements

• Strong organization, multi-tasking and communication skills are key attributes of the successful candidate. Individuals with regulatory writing experience in the context of bioanalytical sciences, and having peer reviewed publications and/or presentations will be strong candidates for this role.
• In-depth understanding of “fit-for-purpose” and fully compliant bioanalytical assay development is also a requirement to support drug discovery and development at various stages.
• Ability to work with ELN, web-based applications, and other information technology tools is required.
• Experience in developing and qualifying internal methods and transferring to CRO’s for late-stage development support is a requirement.
• The position requires strong expertise in FDA/EMA, GLP regulatory requirements and preclinical bioanalytical data management (both GLP and non-GLP) including data transferring, analysis, and reporting.