The Senior Director, Biological Analytical Development provides leadership and hands‑on technical expertise for analytical aspects of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high‑quality methods, specifications, and regulatory documentation to enable clinical development and regulatory submissions.
Responsibilities
* Provide scientific and operational leadership of biological analytical development activities from early stage through validation and transfer to QC.
* Oversee external partners and direct reports while engaging in hands‑on work such as reviewing data, drafting regulatory sections, and troubleshooting technical issues.
* Define and implement phase‑appropriate analytical strategies for biologics drug substance, drug product, intermediates, and critical components.
* Oversee method scouting, qualification, validation and tech transfer in accordance with appropriate regulatory requirements.
* Ensure robust stability programs, reference standards, and specifications are developed and maintained.
* Conduct and/or oversee characterization studies, comparability assessments, and product risk assessments.
* Support and mentor a team of scientists; provide coaching while contributing directly to program deliverables.
* Manage interactions with CDMOs and testing laboratories, ensuring timelines and quality standards are met.
* Draft and review regulatory documents (IND, IMPD, BLA/MAA) and contribute to agency meeting preparations.
* Partner with Regulatory CMC, Quality, and other functions to ensure compliance with global regulations.
* Participate in the Analytical Development Leadership Team and contribute to strategy setting across modalities.
Travel
Occasional domestic and international travel to visit contractors for project reviews or to support ongoing development.
Qualifications
* At least 10 years of hands‑on experience in biologics analytical development and method validation (previous managerial experience a plus) for Analytical Development from Phase 1 to approval.
* Experience in characterization of biologics and in generating data analysis reports for regulatory filings and analytical comparability assessments.
* Experience managing contract development.
* Experience in addressing regulatory queries and authoring analytical sections of IND/IMPD or BLA/MAA.
* Preferred – experience leading a CMC Development Team.
* Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
* Excellent written and verbal communication skills.
Required/Preferred Education and Licenses
The position requires a B.Sc. or M.Sc. in Analytical Chemistry/Science/Biotechnology/Science/Engineering or related field.
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