Summary of Position:The Senior Director, Drug Substance Process Development supports drug substance process development, manufacturing, technical oversight, and product lifecycle activities in collaboration with our external manufacturing partners. In this role, the Senior Director will provide active management of small molecule drug substance contract manufacturers worldwide to ensure the successful manufacture and tech transfer of drug substance processes supporting IST's commercial products as part of a virtual manufacturing organization. Responsibilities include supporting commercial product disposition activities as well as deviations, CAPAs, and change controls as well as process optimization, preparing and reviewing regulatory filings, and life cycle management (CPV) to support development and commercial requirements incolloboration with CMC team members from IST's internal and global partners.
Responsibilities:- Lead and coordinate CMO cGMP manufacturing activities including but not limited to scheduling, production, process transfer, validation, cleaning, and supply chain logistics.
- Support and lead chemistry and engineering development of drug substance processes with focus on manufacturing process development, scale-up, process optimization, technology transfer and validation for commercial manufacturing.
- Review commercial & clinical batch records, investigations related to manufacturing deviations, out-of- specification (OOS) results, and other quality-related incidents.
- Establish and maintain continued process verification (CPV) programs and KPI's to ensure proactive control and monitoring utilizing process data analytics.
- Address technical and quality issues/investigations (Deviations, OOS, OOT) at CMO's to assure GMP compliance prior to QA release; utilize IST quality systems to document review and oversight.
- Coordinate cross-functional activities between CMC, Quality, Regulatory, EHS, Supply Chain, etc.
- Manage relationships with contract manufacturing partners and ensure that outsourced manufacturing operations meet established quality and delivery standards.
- Act as person in plant during key manufacturing operations, address technical and quality issues, and support audits and inspections.
- Utilize continuous improvement tools to develop route/production/cost improvement programs in collaboration with CMO team.
- Author and review drug substance CMC Module 3 sections including regulatory investigational (IND/CTA), registrational (NDA/MAA), and post approval submissions.
Experience & Education:- An advanced (Masters or PhD) degree in Chemical Engineering or Chemistry required
- 15 plus years of CMC experience in small molecule development and commercial manufacturing
- Significant experience working in and providing vendor oversight of an outsourced "virtual manufacturing" environment.
- In-depth knowledge of industry manufacturing, quality, and regulatory practices in small molecules drug substance manufacturing and supply chain,
- Deep expertise in small molecule API development, manufacturing, and control strategies.
Skills and Abilities:- Excellent communication and interpersonal skills, with the ability to effectively engage and influence a broad range of internal and external stakeholders at all levels of the organization. Experienced in process development, tech transfers, and clinical and commercial manufacture of drug substance processes and managing associated commercial production and activities.
- Strong understanding of typical unit operations and related drug substance process equipment.
- Experience and understanding of analytical methods related to drug substance manufacturing (i.e., HPLC, GC, IR, MS, NMR, etc.).
- Demonstrated expertise in process troubleshooting and application of continuous improvement methodologies (i.e., Six Sigma).
- Process R&D experience with development and scale-up, lab to plant, through all phases of development, process validation, and commercial manufacturing.
- Experience with implementing Quality by Design including DoE, fate and tolerance, and risk analysis.
- Up to date knowledge of ICH guidelines and FDA guidance's related to pharmaceutical development, manufacturing, and stability of drug substance.
- Experience managing relationships, influencing and negotiating, and interacting in a matrix environment and with CMO drug substance manufacturers.
- Ability to drive change and work effectively across both internal and external cross functional teams.
- A proven track record of delivering results and is action oriented.
- Ability to manage multiple priorities and operate effectively fast-paced, dynamic environment while maintaining a high level of quality and attention to detail.
- Proactive, strong organizational and time management skills.
- Willingness and ability to travel 10% to 20% domestic/international travel for interactions with CDMOs for critical project activities.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
