JOB DETAILS

Director, Bioanalytical Further Information

Job Details

Location

East Coast US

Region

North America

Position

Full-Time

Salary

$150,000 - $200,000 USD per annum + Bonus

REF

CJ-SCI-DB

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Director, Bioanalytical

Scientific

Cartwright James is currently representing a leading Gene Therapy company. They are currently seeking a Director, Bioanalytical, to be based out of their East Coast US office.

Reporting directly to the Sr. Director of Pharmacology, the successful candidate would be responsible for managing and coordinating bioanalytical assay method development and sample testing to support all projects in the company portfolio for both nonclinical and clinical activities. They will be responsible for ensuring timely and on budget assay availability and execution by working closely with contract research organisations and internal functional teams.

Key responsibilities include:

  • Establish appropriate methods in each species and matrix required (human, mouse, rat, dog, etc); to meet required development program time lines.
  • Establish a bioanalytical assay plan for each project that provides both time lines and budgets.
  • Identify and qualify vendors (CRO’s) and obtain cost estimates for bioanalytical project requirements
  • Review assay development, validation, and stability data to ensure method provides adequate accuracy, precision, reproducibility and compliance with regulatory requirements
  • Ensure on-time delivery of bioanalytical data to project team by working closely with and providing technical expertise input to both the project team and the CROs. Review and edit all bioanalytical study reports from CROs.
  • Support the Business Development function by participating in due diligence and GAP analysis of bioanalytical support for new assets

Qualifications:

  • PhD preferred, or MS with equivalent experience
  • 5-10 years pharmaceutical or CRO industry, with knowledge and experience in aspects of drug development
  • Bioanalytical support for Gene Therapy product development
  • Previous experience in providing scientific oversight to outsourced bioanalytical assays
  • Proven ability to manage multiple projects/tasks at one time
  • Excellent written and oral communication skills

Cartwright James is a global executive search and selection company based in the UK, providing expert knowledge and bespoke services in the international Chemicals, Medical and Scientific markets. We receive a vast volume of applications for each position, therefore it takes time to assess each candidate. We will be in touch if the candidates experience matches the job requirements.

Job Reference: CJ-SCI-DB

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