研发总监

About the Company

Dongguan White Oak Pharmaceutical Co., Ltd. is a leading CDMO dedicated to the R&D and manufacturing of small nucleic acid drugs. We deliver high-quality, end-to-end solutions to our clients, driving innovation and progress in the global biopharmaceutical industry.

About the Role

We are seeking a seasoned leader to oversee the technical development and production management of our small nucleic acid API business. The role will ensure operational excellence, resolve critical technical challenges, and drive continuous team optimization and innovation.

Key Responsibilities

• Technical Development: Lead CMC (Chemistry, Manufacturing and Control) research, process optimization, technology transfer, scale-up and pilot production of small nucleic acid APIs; resolve core technical challenges (impurity control, yield improvement, etc.); drive platform process iteration and cross-departmental collaboration with formulation, analysis and quality teams.
• Production Management: Oversee end-to-end CDMO project operations to ensure on-time, high-quality delivery of client orders; resolve production technical issues (process scale-up, batch consistency, etc.); optimize production plans, workflows and capacity utilization; coordinate internal teams (QC, QA, Synthesis, Formulation) and external stakeholders (clients, CRO partners).
• Compliance & Innovation: Ensure full compliance with ICH, GMP, FDA, EMA and NMPA regulatory requirements; lead SOP development and upgrades; track industry trends (continuous manufacturing, gene therapy, etc.) to drive technological advancement; support client and regulatory audits.
• Cost Control: Drive R&D and production cost reduction, resource efficiency and lean manufacturing; manage budgets and monitor raw material, equipment and labor costs.
• Client Collaboration: Liaise with clients to align technical requirements, resolve project issues, provide regular progress updates, and maintain long-term strategic partnerships.
• Team Management: Lead R&D and production teams (utilities, formulation workshop, process equipment, etc.), cultivate technical talent, and implement performance management systems to enhance team efficiency.

Requirements

• PhD in Pharmacy, Chemistry, Biotechnology or a related discipline.
• 8+ years of pharmaceutical R&D and manufacturing experience, with 3+ years of R&D management experience in a small nucleic acid CDMO.
• Proven expertise in the full drug development lifecycle (pre-clinical to commercialization); successful IND/ANDA submission experience is highly preferred.
• Deep understanding of CDMO industry dynamics and client-centric service delivery.
• Mastery of global pharmaceutical regulations (GMP, FDA, EMA, NMPA, ICH) with a strong compliance mindset.
• Exceptional team building, cross-functional collaboration, coordination and stress management capabilities.
• Advanced English proficiency for technical literature review and client communication.

Compensation

Competitive compensation package will be offered commensurate with the candidate’s experience and expertise.

Equal Opportunity Employer

White Oak Pharma is an equal opportunity employer committed to fostering a diverse, inclusive and equitable workplace. We welcome applications from all qualified candidates regardless of background.