Associate Director Bioanalytical Sciences
Waltham, MA 
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Posted 18 days ago
Job Description

Associate Director Bioanalytical Sciences

Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Description of duties: We are seeking a highly motivated candidate with hands-on experience in developing small and large molecule assays and sample analysis. The successful candidate will support Discovery, Preclinical, and Clinical Development programs as representative on the bioanalytical team. He/she will also represent the PK/PD discipline on large molecule discovery project teams.

  • He/she is responsible for developing and implementing the discovery PK, PK/PD and bioanalytical strategy for Alkermes' discovery, preclinical and clinical development programs, ensuring that PK/PD and bioanalytical support is completed in a timely manner, meets current scientific and quality standards, and adequately supports regulatory submissions.
  • Responsible for providing scientific and technical oversight to the bioanalytical vendor during method development, transfer, validation, and sample analysis. Responsible for providing strategic input and scientific expertise to program teams on all issues relevant to PK/PD and 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 clinical study reports. Responsible for preparing and/or providing input on regulatory documents including: CTA, IND, LBA, NDA.
  • Perform analysis of biological samples to support drug discovery & development for potential small and large molecules candidates using LC-MS/MS, hybrid LC-MS/MS, cell-based and ligand binding assays and oversight method development, method validation & sample analysis at CRO.
  • He/she is expected to continuously and proactively advise teams and management on the development and optimization of bioanalytical technologies, strategies and models to improve the quality and productivity of the function. He/she will be a member of the Clinical Pharmacology and Translational Medicine team, partnering with Discovery and Nonclinical Safety Evaluation colleagues as well as Clinical Development colleagues to identify and manage external vendor support of GLP/GCP sample analysis.
  • He/she 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 10+ years of experience

Preferred Requirements:

  • Development of LC/MS/MS, cell-based and ligand binding assays for the quantitation of small molecules and biologics and in large molecule discovery PK/PD.
  • Understanding of "fit-for-purpose" assay development and support is also a requirement as is strong knowledge of bioanalysis under regulated conditions in support of drug development.
  • 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/GCP regulatory requirements and Clinical bioanalytical data management (both GLP and non-GLP) including data transferring, analysis, and reporting.
  • Prior experience with laboratory and vendor management is required. 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 first-author, peer reviewed publications and/or presentations will be strong candidates for this role.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.

#LI-HB1

Experience Level:
Mid-Senior Level

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
15+ years
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