Principal Scientist, Clinical & Nonclinical Bioanalysis en Commercial
Commercial · Waltham, Estados Unidos De América · Onsite
- Senior
- Oficina en Waltham
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.
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Company
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
