Director, Drug Substance Manufacturing & Development

We are seeking an Associate Director responsible for phase-appropriate small molecule drug substance development. This critical hire will bring a strong process development background and experience managing external vendors and will define and execute on a strategy for synthetic route, process optimization, site transfer, scale-up and validation.

• Subject matter expert for all aspects of drug substance process and controls.
• Manage development and manufacturing activities at drug substance CDMOs.
• Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria.
• Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records.
• Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy.
• Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection.
• Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations.
• Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission.
• Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization.
• Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.

Qualifications:

• Degree in Organic chemistry - Bachelor’s/Master’s degree with 12+ years of experience or PhD degree with 8+ years of experience.
• Subject matter expert in small molecule drug substance production techniques, processing, and characterization and have a demonstrated track record of successful CDMO management.
• Extensive experience in small molecule cGMP manufacturing and proficient knowledge of ICH Q7 guidelines.
• Experience in evaluating and setting phase appropriate controls including raw material, in-process, intermediate, and final drug substance specifications. Familiar with ICH guidelines as they relate to these controls.
• History writing, reviewing and approving quality documents (batch records, SOPs, change controls) and participating in quality events (deviation investigation, CAPA, audits).
• Experience writing, reviewing and approving technical documents including development reports, risk assessments, and regulatory drug substance sections (IND, IMPD,NDA).
• Working knowledge of solid-state development and characterization. The ability to lead polymorph, salt/co-crystal evaluation, and selection. Familiar with the use of XRPD, DSC, TGA, DVS, PSD, and microscopy to support characterization.
• Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers.
• Detail oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
• Ability to troubleshoot problems, work within a team.
• Ability to manage multiple projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
• Ability to travel internationally and within the USA up to 10 – 30%, as required, to meet project objectives.

Salary Range:

$210,000 - 240,000 USD