Director Analytical Development

A clinical-stage biotechnology company is developing novel, potentially disease-modifying therapies for autoimmune diseases using advanced biologic and cell engineering approaches. The organization is science-driven, highly collaborative, and focused on translating cutting-edge research into meaningful patient impact.

Position Summary:

We are seeking an experienced Director of Analytical Development to lead analytical strategy and execution in support of a biologics-focused autoimmune pipeline. This role sits within the CMC organization and will oversee all analytical development activities for biologic drug substance and drug product, including monoclonal antibodies and fusion proteins.

The successful candidate will play a key role in advancing programs from early development through clinical stages, working closely with internal CMC functions and external CDMOs. This is a hands-on leadership role in a fast-paced biotech environment, requiring strong scientific judgment, cross-functional collaboration, and deep knowledge of biologics analytics and cGMP expectations.

Key Responsibilities:

• Define and execute phase-appropriate analytical control strategies for biologic drug substance and drug product.
• Lead method development, qualification, validation, release, and stability testing for monoclonal antibodies, fusion proteins, and related biologics.
• Provide oversight and scientific leadership for key analytical methods supporting identity, purity, potency, and stability.
• Collaborate closely with Process Development, Formulation, Quality, Regulatory, and CMC leadership to align analytical and program strategies.
• Manage analytical activities at external CDMOs/CROs, including method transfer, troubleshooting, and timeline oversight.
• Author and review analytical documentation, including methods, reports, specifications, and regulatory CMC sections.
• Build, mentor, and lead members of the Analytical Development team.

Required Qualifications:

• Ph.D. with 8+ years, or M.S. with 12+ years, of analytical development experience in biotech or pharma.
• Strong background in biologics analytical development (mAbs, fusion proteins, or complex protein therapeutics).
• 5+ years of leadership experience, including management of internal and/or external teams.
• Expertise in biologics analytical techniques such as HPLC/UPLC, CE, MS, SEC, icIEF, peptide mapping, and potency assays.
• Solid understanding of cGMP and regulatory expectations for biologics.
• Excellent communication, organization, and problem-solving skills.

If interested, please apply directly or contact me on the following details for more information: