Director, Formulation Development – Biologics (Taiwan)
Location: Taiwan
Department: CMC / Technical Development
Reports To: Senior Vice President, CMC
Position Summary
Our client is seeking an experienced and strategic Director of Formulation Development to lead biologics drug product development activities supporting our expanding pipeline of large molecule therapeutics. This individual will provide scientific and operational leadership for formulation and drug product development from early-stage research through clinical and commercial manufacturing.
The ideal candidate will possess deep expertise in biologics formulation sciences, including monoclonal antibodies and recombinant proteins, and have experience working within global CMC environments. This role will collaborate closely with Process Development, Analytical Development, Quality, Regulatory Affairs, and external CDMO partners to deliver robust, stable, and scalable drug product solutions.
Key Responsibilities
Formulation & Drug Product Development
- Lead formulation development activities for biologic therapeutics including monoclonal antibodies, recombinant proteins, and other large molecule modalities.
- Design and optimize liquid and lyophilized formulations to support stability, manufacturability, and patient administration requirements.
- Oversee excipient selection, formulation screening, forced degradation studies, and long-term stability programs.
- Support development of high-concentration formulations and device compatibility assessments where applicable.
- Lead drug product process development activities including fill-finish process support and technology transfer.
Technical Leadership
- Build and lead a high-performing formulation development team in Taiwan.
- Establish scientific strategies and phase-appropriate development plans aligned with regulatory expectations and project timelines.
- Provide technical leadership for formulation characterization, comparability assessments, and product lifecycle management.
- Collaborate closely with analytical sciences to define critical quality attributes and stability-indicating methods.
Cross-Functional Collaboration
- Partner with Process Development, Manufacturing, Quality, and Regulatory Affairs to ensure successful progression of development programs.
- Serve as the formulation representative on cross-functional project teams and governance meetings.
- Manage external CDMOs and testing laboratories supporting formulation and drug product activities.
Regulatory & Quality Support
- Contribute to IND, IMPD, BLA, and other global regulatory submissions.
- Author and review technical reports, protocols, and CMC documentation.
- Ensure activities are conducted in compliance with applicable GMP and ICH guidelines.
- Support regulatory inspections, audits, and quality investigations as needed.
Qualifications
- PhD or MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
- 10+ years of relevant industry experience in biologics formulation and drug product development.
- Strong expertise in formulation development for monoclonal antibodies, recombinant proteins, or other biologic therapeutics.
- Experience with stability studies, freeze-thaw characterization, aggregation mitigation, and high-concentration formulations.
- Demonstrated experience supporting clinical and/or commercial biologics programs.
- Strong understanding of CMC development requirements and global regulatory expectations.
- Experience managing CDMOs and external partners preferred.
- Excellent leadership, communication, and project management skills.
- Fluent in English and Taiwanese Mandarin
