Director, Drug Substance Manufacturing & Development

About the role

The Associate Director will be responsible for phase-appropriate small molecule drug substance development. This role will involve managing development and manufacturing activities at drug substance CDMOs, leading route selection, scale up, and process control development, and providing support for regulatory filings.

Responsibilities

• 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.

Pay

Salary Range: $210,000 - 240,000 USD
Target Bonus: 20%

Benefits

• Cover 100% of medical, dental, and vision premiums for you and your family.
• Fund up to 75% of in-network deductibles.
• 401(k) match with immediate vesting.
• Generous paid time off.
• 12 weeks of fully paid parental leave.
• Paid family and medical leave for all employees regardless of location.
• Company-paid short-term disability coverage for up to 20 weeks.
• Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support.