Associate Director/Director, CMC, Technical Operations

Role Summary

Associate Director/Director, CMC, Technical Operations. BridgeBio is seeking an experienced antibody manufacturing and analytical development scientist to expand its biologics-based pipeline, develop analytical methods, and support process and formulation development for antibodies in rare diseases. This role involves collaboration with CRO/CDMO/CMO partners, and requires prior experience with antibodies and CMC analytical requirements for IND/NDA/MAA filings.

Responsibilities

• Develop analytical methods, and support extended characterization studies for antibody-based therapeutics
• Support process and formulation development by providing analytical testing results
• Collaborate with CRO/CDMO/CMO to ensure timely development, validation, testing, and release of materials for clinical activities
• Author and review protocols, technical reports, and method SOPs
• Author and review module 3 sections for US and ex-US regulatory filings
• Manage CRO/CDMO/CMO analytical development activities and timelines
• Review analytical method transfer documentation and release/stability data for drug substance and drug product
• Participate in CMC strategic planning and department leadership meetings

Qualifications

• PhD with 8‚Äì10 years or non-PhD with 10‚Äì15 years of relevant industry experience
• Experience with state-of-the-art analytical technologies for biologics (HPLC, CE-SDS, icIEF, LC-MS, peptide/glycan/disulfide maps, DSC, FT-IR, CD, fluorescence, particle analysis)
• Expertise with current analytical techniques for pharmaceutical development
• Thorough understanding of cGMPs, USP, ICH guidelines, and industry best practices
• Experience managing CDMO/CRO from cell line development to IND/FIH
• Ability to communicate effectively with CRO/CDMO/CMO on project scope, results, and updates
• Knowledge and experience with CMC analytical requirements for IND and NDA/MAA filings
• Strong oral and written communication skills
• Proven leadership and personnel management abilities

Skills

• Analytical method development and transfer
• Regulatory filing support (Module 3, US and ex-US)
• CMC strategy and cross-functional collaboration
• Project management and CRO/CDMO oversight

Education

• Doctorate or equivalent experience in a relevant field (e.g., Biochemistry, Analytical Chemistry, Pharmaceutical Sciences)