Executive Director, MFG Sciences and Technology

Role Summary

The Executive Director of Pharmaceutical Manufacturing Sciences and Technology will be a strategic leader and technical expert, driving the development and execution of manufacturing processes, technology transfer, and process optimization for pharmaceutical products. He or she ensures cGMP compliance, global regulatory compliance, and operational excellence for both Drug Substance and Drug Product. The position supports products at all phases of development from pre-clinical through support of globally marketed commercial products.

Responsibilities

• Strategic Leadership:
  • Develop and execute the overall strategy for Manufacturing Sciences and Technology, aligning with company objectives.
  • Provide leadership and direction to the CMC development and MFG support teams, fostering a culture of innovation and excellence.
  • Oversee the project related budgets and resources for the department, ensuring efficient and effective allocation of both.
• Technical and Business Requirements:
  • Serve as the technical expert for Drug Substance and Drug Product manufacturing processes, providing guidance on problem-solving, global regulatory strategy, process deviation resolution, and process optimization for clinical and commercial products.
  • Lead the development and execution of manufacturing strategies, including process development, technology transfer, process validation, industrialization, launch and life cycle management.
  • Ensure that all manufacturing processes are compliant with regulatory standards (cGMP, FDA, ICH etc).
  • Develop budgets for development, industrialization, launch and ongoing manufacturing that meet or exceed those targeted by the business.
  • Assist finance in preparing and maintaining COGS models for all Rigel products.
  • Draft and review global regulatory submission content and answer CMC related queries from both partners and health authorities.
• Technology Transfer and External Partner Management:
  • Direct technology transfer activities to external contract manufacturing organizations (CMOs) and provide ongoing technical oversight of manufacturing activities worldwide.
  • Support external partner facility fit assessment, tech transfer activities, and coordination of process start-up activities.
  • Ensure robust monitoring of key metrics and work with CMOs to manage deviations and ensure compliance during routine manufacturing of both clinical and commercial products.
• Collaboration and Communication:
  • Collaborate effectively with internal and external cross-functional teams, including R&D, Quality Assurance, Regulatory, Engineering, Supply Chain, CMOs, and Commercial Operations, to ensure seamless execution of manufacturing strategies.
  • Communicate effectively with stakeholders, including internal and external partners, to ensure alignment and transparency.
• Process Improvement and Innovation:
  • Identify and implement process improvements and innovations to enhance efficiency, quality, and cost-effectiveness.
  • Stay abreast of the latest advancements in pharmaceutical manufacturing technologies and processes as well as evolving global regulatory standards.

Qualifications

• PhD in chemistry or a related field with a minimum of 15 years of relevant industry experience, or MS in same or similar field with a minimum of 18 years of relevant industry experience.
• Expert on MFG of small molecule drug substance and oral solid drug product, development and validation of manufacturing processes for same.
• Working knowledge of regulatory requirements including ICH, FDA, EMA and Health Canada guidelines on CMC development and MFG of both Drug Substance and Drug Product.
• Working experience with writing CMC documents for regulatory filings for clinical studies and commercial marketing applications as well as annual reporting.
• Experience of evaluating and working with CMO/CROs.
• Ability of multiple tasking in fast-pace working environment under tight timeline.
• Ability to develop and manage budgets for both the department and on a product specific basis.
• Effective communication, able to work with others attention to detail.

Education

• PhD in chemistry or related field (or MS with extended relevant experience as alternative).

Additional Requirements

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand for extended periods of time and able to lift 10 lbs. Some travel required.
• WORK ENVIRONMENT: This is a hybrid position based at Rigel HQ in South San Francisco CA which requires a minimum of 2 days onsite per week. Remote applicants may be considered.
• Travel: Some degree of both US and international travel is expected.