Associate Director, Analytical Development (Biologics)

Key Responsibilities

• Lead the development, qualification, validation, and transfer of analytical methods across the product lifecycle for biologics programs.
• Support the selection and oversight of contract development and manufacturing organizations, and contract laboratories.
• Provide technical oversight for analytical methods supporting reference standards, starting materials, intermediates, release testing, stability testing, drug substance, and drug product.
• Manage analytical activities performed by external contract laboratories, ensuring scientific rigor, technical alignment, and compliance with applicable quality standards.
• Develop and implement analytical strategies appropriate for each stage of CMC development and consistent with evolving regulatory expectations.
• Author and provide technical review of relevant CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, MAAs, and related filings.
• Design and manage non-GMP and cGMP stability programs for drug substance and drug product batches, providing scientific guidance to support shelf-life and expiry dating recommendations.
• Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and external partners to ensure analytical plans are integrated with overall program objectives.
• Provide analytical expertise in support of out-of-specification results, deviations, non-conformance investigations, root cause analyses, and CAPA development.
• Serve as a key member of the CMC and Technical Operations team, contributing to cross-functional execution, continuous improvement, and a strong quality culture.

Qualifications

• PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 15 years industry experience
• Demonstrated experience in analytical development, method validation, method transfer, and molecular stability management within a regulated biopharmaceutical or pharmaceutical environment.
• Strong working knowledge of biologics CMC development, including complex modalities such as multi-specifics, as well as cGMP expectations, quality systems, and regulatory submission requirements.
• Experience managing external consultants, contract laboratories, CMOs, or CDMOs, with a proven ability to drive technical alignment across internal and external stakeholders.
• Experience supporting biologics, protein therapeutics, or other complex modalities from early development through clinical-stage execution.
• Track record of authoring or reviewing CMC content for IND, IMPD, BLA, MAA, or related regulatory submissions.
• Hands-on experience with HPLC, UHPLC, and LC-MS, including SEC, RP, and IEX chromatography. Experience with drug product assays, stability testing, formulation-related analytical methods, such as CE-SDS, icIEF, binding and potency assays, and impurity/residual testing, including HCP, DNA, and residual Protein A, is preferred.

Success Profile

• The successful candidate will be a collaborative and scientifically rigorous leader who balances strategic thinking with hands-on technical problem solving.
• This individual will communicate effectively across functions, manage external partners with accountability, and help deliver high-quality CMC outcomes in a fast-paced development environment.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $172,000 - $215,000 annually; however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.