Cogent Biosciences · 2 months ago
Associate Director, Drug Substance Manufacturing & Development
United States
Full-time
Remote
Lead/Staff, Director/Executive
$170K/yr - $210K/yr
8+ years expCogent Biosciences is a biotechnology company dedicated to developing precision therapies for genetically defined diseases. The Associate Director will be responsible for phase-appropriate small molecule drug substance development, managing external vendors, and executing strategies for process optimization and validation.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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
Benefits
Competitive pay
Performance-based bonus
Stock options
Insurance coverage (health, dental, life, and disability)
Competitive time-off
A 401(k) plan
Commuter/parking benefits
Company
Cogent Biosciences
Cogent Biosciences is a biotechnology company that develops therapies for solid cancer tumors.
51-200 employees
H1B Sponsorship
Cogent Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.6BKey Investors
Commodore CapitalFairmount Funds ManagementSquare 1 Bank
2025-11-10Post Ipo Equity· $200M
2025-11-10Post Ipo Debt· $200M
2025-07-08Post Ipo Equity· $230M
Leadership Team
Andrew Robbins
CEO and President
A
Abb Hayden
Senior Vice President of Sales
Recent News
2025-12-31
Company data provided by crunchbase