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Open nowFirst seen 4 days ago

Product Development Director (R&D | Pharma)

HRTX1,628 open roles

Where
Calamba, Laguna, Philippines
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Your applicationOpen nowProduct Development Director (R&D | Pharma)HRTX · Calamba, Laguna, Philippines

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

The posting

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
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