The Director of Process Chemistry, Drug Substance will be a technical subject matter expert, supporting the design, development and execution of manufacturing processes, technology transfer, and process optimization for pharmaceutical Drug Substance processes. The position holder contributes to ensure GMP compliance, global regulatory compliance, and operational excellence for Drug Substance processes. The position supports products at all phases of Drug Substance development from pre-clinical through support of globally marketed commercial GMP products. The position holder will be a highly motivated, proactive team player with a strong background in organic chemistry and a proven track record of accomplishments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Strategic Leadership:
- Support executing the overall strategy for Manufacturing Sciences and Technology for Drug Substance products, aligning with company objectives.
- Provide technical expertise and scientific input on DS process chemistry to the CMC team.
- Technical Expertise:
- Serve as the technical expert for Drug Substance development and manufacturing processes, providing guidance on problem solving, global regulatory strategy, process deviation resolution, and process optimization for clinical and commercial products.
- Support the development and execution of Drug Substance development and manufacturing process strategies, including process development, technology transfer, process validation, launch and life cycle management.
- Ensure that all Drug Substance development and manufacturing processes are compliant with regulatory standards (GMP, ICH, FDA, etc.).
- Technology Transfer and External Partner Management:
- Support Lead Drug Substance technology transfer activities to external contract manufacturing organizations, 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 as needed.
- Contribute to ensure robust monitoring of key metrics and work with CMOs to manage deviations and ensure compliance.
- Collaboration and Communication:
- Collaborate effectively with internal and external cross-functional teams, including R&D, Quality Assurance, Regulatory, Engineering, Supply Chain, 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 help implement Drug Substance process improvements and innovations to enhance efficiency, quality, and cost-effectiveness.
- Stay abreast of the latest advancements in pharmaceutical manufacturing technologies and processes.
KNOWLEDGE AND SKILL REQUIREMENTS
- PhD in chemistry or a related field, with a minimum of 15 years of relevant industry experience
- Expert on MFG of small molecule development, QbD, and validation of manufacturing processes for Drug Substance products.
- Working knowledge of regulatory requirements including ICH, FDA, EMA, PMDA, TGA and Health Canada guidelines on CMC development and MFG of Drug Substance.
- Working experience with writing CMC documents for regulatory filings for clinical studies and commercial marketing applications as well as annual reporting.
- Prior experience managing small molecule drug substance process design, development and manufacture at CROs and CDMOs is critical for this position.
- Ability of multiple tasking in fast-pace working environment under tight timeline, and in a large range of time zones.
- Effective communication, able to work with others attention to detail.