Director, mRNA Analytical

We are seeking a Director of Analytical Development to join a Biotech who is working to develop first-in-class messenger RNA (mRNA) based therapeutics and vaccines.

Job Responsibilities:

• Build and manage a strong analytic team.
• Lead analytic method development and execute analytical assays of gene therapeutics in process development and CMC.
• Lead efforts to design, develop, and execute bioassays of in vitro and in vivo samples to understand DMPK and activities of gene therapeutic candidates and advance gene therapy projects into IND filings.
• Support tech transfer and on-going activities with external collaborators and service providers (CMO, CROs).
• Maintain accurate, timely, and detailed records of work.
• Communicate and present findings in internal and external meetings.
• Collaborate across the company to ensure that timelines developed are adhered to by appropriate internal and external resources assignments.

Skills and Requirements

• D. in biology, virology, or a related field with ten years of industry experience in developing analytic assays for mRNA or Oligo therapeutics, and in vitro assays for preclinical research applications.
• Prior experience in establishing analytical methods and conducting analytical assays is required.
• Prior experience in establishing conducting bioassays for preclinical in vitro and in vivo studies is required.
• Experience with writing assay protocol, documentation, and study reports that could contribute to regulatory filing documents is a plus.
• The ability to work independently and be part of a team is essential; possess self-motivation, adaptability, and a positive attitude.
• Ability to balance multiple projects under a demanding timeline while providing guidance to project teams.
• Skilled in developing molecular biology test methods, including PCR, ELISA, HTRF, SDS Page, and cell-based potency assays.
• Hands-on experiences in analytics are required.
• Excellent organizational, communication, and collaboration skills are required.
• Experience in authoring regulatory documents, including IND, is required.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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