Director, Drug Substance Manufacturing – Development

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Associate Director managing drug substance development for precision therapies at Cogent Biosciences. Lead process optimization and vendor management in biotechnology.

Posted 7/16/2026full-timeRemote • 🇺🇸 United StatesLead💰 $210,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in small molecule drug substance production, including process control development, regulatory documentation, and quality management. Proven ability to lead cross-functional teams and manage CDMO relationships while ensuring compliance with cGMP and ICH Q7 guidelines.

Highest-signal resume keywords

Small Molecule Drug Substance ProductionCGMP ManufacturingRegulatory Documentation (IND, NDA)Process Control DevelopmentQuality Management (CAPA, Deviation Investigation)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Organic ChemistryProcess Control DevelopmentImpurities Fate AnalysisSolid-State DevelopmentTechnical Document ReviewPhase Appropriate ControlsCritical Process ParametersQuality Document WritingRisk AssessmentBatch Record Approval

Soft Skills

Detail OrientedStrong Written CommunicationStrong Oral CommunicationCollaborativeProblem Solving

Industry Keywords

CDMO ManagementICH Q7 GuidelinesQuality EventsChange ControlMultidisciplinary Team Environment

Tech Stack

Tools & technologies

SaltStack

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
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, ability to lead polymorph, salt/co-crystal evaluation, and selection.
Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers.
Detail oriented, strong written and oral communication skills, and proven history of working with others in a multidisciplinary team environment.
Ability to manage multiple projects simultaneously and creative in developing strategies for solving problems.
Ability to travel internationally and within the USA up to 10 – 30%, as required.

Benefits

Comp & perks

100% coverage of medical, dental, and vision premiums for employees and families
Funding 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
Company-paid short-term disability coverage for up to 20 weeks
Wellness programs
Tuition reimbursement
Inclusive family-forming support