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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