Vice President, CMC (Large Molecule Biologics)
Location: Taiwan
Onsite
Position Summary
The Vice President of Chemistry, Manufacturing & Controls (CMC) will provide strategic and operational leadership across all CMC functions to support the development and commercialization of large molecule biologic therapeutics. This executive will lead Process Development, Analytical Development, Formulation Development, and Quality functions, ensuring successful advancement of programs from early development through clinical and commercial manufacturing.
The VP, CMC will serve as a key member of the senior leadership team and will be responsible for building scalable CMC infrastructure, establishing external partnerships, and driving regulatory-ready development strategies for biologics programs.
Key Responsibilities:
CMC Strategy & Leadership
- Develop and execute an integrated CMC strategy aligned with corporate objectives and program timelines.
- Lead all technical development activities across process development, analytical sciences, formulation development, and quality.
- Build and mentor high-performing technical teams and organizational capabilities.
- Provide strategic oversight of CMO/CDMO relationships and manufacturing partnerships.
- Collaborate cross-functionally with Regulatory, Clinical, Supply Chain, Program Management, and Executive Leadership.
Process Development
- Lead upstream and downstream process development activities for monoclonal antibodies, recombinant proteins, or other biologic modalities.
- Oversee process characterization, scale-up, technology transfer, and manufacturing support activities.
- Ensure robust, scalable, and phase-appropriate manufacturing processes for clinical and commercial supply.
- Drive process robustness, comparability assessments, and lifecycle management strategies.
Analytical Development
- Direct development, qualification, validation, and transfer of analytical methods supporting biologics characterization and release testing.
- Ensure comprehensive understanding of product quality attributes, stability, and comparability.
- Oversee analytical support for regulatory submissions, manufacturing investigations, and specification setting.
Formulation Development
- Lead formulation and drug product development activities, including stability studies and delivery strategies.
- Develop formulations suitable for clinical and commercial use, considering manufacturability, stability, and patient needs.
- Support device combination products and fill-finish strategies as applicable.
Quality & Compliance
- Provide executive oversight for Quality Assurance and Quality Control functions.
- Ensure compliance with global GMP regulations and inspection readiness.
- Partner with Regulatory Affairs to support IND, BLA, MAA, and other global submissions.
- Establish quality systems appropriate for clinical-stage through commercial operations.
Regulatory & External Engagement
- Represent CMC functions in interactions with regulatory agencies, partners, investors, and board members.
- Author and review CMC sections of regulatory filings and briefing documents.
- Support due diligence activities, partnerships, and strategic business initiatives.
Qualifications
- PhD, MS, or equivalent advanced degree in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, or related discipline.
- Minimum 15+ years of biopharmaceutical industry experience, including significant leadership experience in CMC for large molecule biologics.
- Demonstrated expertise across biologics process development, analytical development, formulation sciences, and quality operations.
- Proven experience advancing biologic programs from preclinical through late-stage clinical development and/or commercialization.
- Deep knowledge of CMC regulatory requirements for biologics, including FDA, EMA, and ICH guidelines.
- Track record of building and leading high-performing technical organizations.
- Experience supporting regulatory inspections and major filings (INDs, BLAs, MAAs).
- Fluency in English and Taiwanese Mandarin.
