Director/Analytical Qualification Lead

COMPANY:

Biotech company focused on CRISPR-based editing technology

LOCATION:

Cambridge, MA

TITLE:

Director, Analytical Qualification Lead

TYPE:

Permanent, direct-hire

ROLE RESPONSIBILITIES:

The Director, Analytical Qualification Lead will design, plan, oversee and coordinate qualification of analytical methods for critical materials, drug substance and drug product for the company's lead gene therapy platforms.

This role will be primarily outward facing, working with CDMO and CTO partners and will be responsible for coordinating activities leading to method qualification, setting and approving of specifications and will collaborate with Quality and SMEs to transfer qualified methods and enable GMP testing and methods validation.

CANDIDATE REQUIREMENTS:

• MS or PhD in relevant scientific field
• Minimum 15 years (MS) or 10 years (PhD) industry experience (including biotech, biopharma, CRO, CDMO) including hands on experience in cell therapy (CAR-T)
• Required direct experience of analytical method development, optimization and qualification for cell therapy or gene therapy.
• Required knowledge and hands on application of analytical methods
• Knowledge and experience in CMC and regulatory strategy, cGMP, ICH guidelines, USP and EP compendial methods applied to cell and gene therapy.
• Extensive scientific writing experience, experience authoring IND and related documentation.
• Familiarity with Next Generation Sequencing is very much desired

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.