Director/Sr. Director of Analytical Development
Director/Sr.Director of Analytical Development (Peptides)
REMOTE
Overview
We are partnered with a well-funded clinical-stage biopharma who is advancing a pipeline of innovative small‑molecule therapies addressing several therapeutics. They are progressing multiple programs across their portfolio, from IND-Enabling to Phase III/Commercialization.
They are seeking a Director of Analytical Development to lead analytical activities for a multi‑asset peptide portfolio, covering both Drug Substance (DS) and Drug Product (DP) from IND through Phase 3 and commercial launch. This role will define analytical strategy, ensure method readiness across development stages, and support successful regulatory submissions and commercialization efforts.
Key Responsibilities
- Lead analytical development strategy for peptide DS and DP across multiple programs.
- Oversee development, qualification, and validation of analytical methods from early clinical through commercial stages.
- Establish and maintain specifications, stability programs, and control strategies.
- Provide analytical leadership for CMC submissions (IND/CTA, Phase 2/3 updates, NDA/BLA).
- Partner cross‑functionally with Process Development, Formulation, Manufacturing, Quality, and Regulatory.
- Lead analytical tech transfers to CDMOs and QC labs; manage external partners.
- Build and lead a high‑performing Analytical Development team.
- Ensure analytical readiness for late‑stage development, PPQ, and commercial launch.
Qualifications
- PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field (or MS/BS with additional experience).
- Extensive experience in peptide analytical development, including DS and DP.
- Proven track record supporting programs from IND through late‑stage clinical and/or commercial.
- Experience with method development, validation, stability, and tech transfer.
- Prior people leadership and CDMO oversight experience strongly preferred.
Ideal Background
- Experience working on multiple peptide & small molecules assets in parallel.
- Comfortable operating in a fast‑moving, evolving CMC organization.
- Strong communication skills and ability to work cross‑functionally.
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