The Director of Pharmaceutical R&D leads the end-to-end development of pharmaceutical products within a toll manufacturing/CDMO environment. This role is accountable for formulation development, process scale-up, and successful technology transfer to commercial manufacturing, ensuring full compliance with regulatory standards and client requirements.
The position plays a critical role in bridging R&D, Operations, Quality, and Regulatory functions to deliver commercially viable, high-quality products on time and within cost targets.
Key Responsibilities:
R&D Leadership & Strategy
- Define and execute the R&D strategy aligned with business objectives, client pipeline, and capability expansion
- Lead formulation development, process optimization, and lifecycle management across multiple dosage forms (e.g., oral solids, liquids, semi-solids)
- Drive capability-building initiatives to strengthen technical expertise and expand service offerings
- Build, mentor, and lead a high-performing, cross-functional R&D team
Formulation Development & Technology Transfer
- Oversee development of formulations based on client requirements, reference products, or regulatory pathways
- Lead pilot-scale trials, process scale-up, and validation readiness
- Ensure efficient and compliant technology transfer from R&D to commercial manufacturing
- Partner closely with Production, QA, and Engineering to ensure manufacturability and robustness of processes
- Provide technical leadership in resolving formulation and process-related issues for commercial products
Regulatory & Technical Compliance
- Ensure all R&D activities comply with GMP, GLP, and relevant regulatory standards (e.g., FDA, ASEAN, PIC/S)
- Review and approve technical documentation including development reports, validation protocols, and product dossiers
- Support regulatory submissions, audits, and responses to technical queries from clients and health authorities
Client & Program Management
- Serve as the primary technical point of contact for clients in a toll manufacturing/CDMO setup
- Lead technical discussions, feasibility assessments, and project planning with clients
- Manage multiple development programs simultaneously, ensuring timelines, cost targets, and deliverables are met
- Provide scientific insights to support business development and client acquisition efforts
Quality, Efficiency & Continuous Improvement
- Ensure strict adherence to internal quality systems and regulatory expectations
- Drive continuous improvement in formulation efficiency, scale-up success rates, and development timelines
- Implement best practices in pharmaceutical development, including QbD (Quality by Design) where applicable
- Optimize resource utilization and cost efficiency across R&D operations
Qualifications:
- Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering, or related field (Master's or PhD preferred)
- Licensed Pharmacist is strongly preferred
- 12–15+ years of experience in pharmaceutical R&D, with at least 5 years in a leadership capacity
- Strong background in formulation development, scale-up, and technology transfer
- Prior experience in a CDMO / toll manufacturing environment is highly preferred
- In-depth knowledge of GMP and international regulatory standards (FDA, ASEAN, PIC/S)
- Proven experience managing multiple client-driven projects simultaneously
- Strong stakeholder management and cross-functional leadership skills
