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.