CG Oncology

Associate Director, Drug Product

CG Oncology

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $166,000 - $195,000 per year

Job Level

Senior

About the role

  • Provide technical and operational leadership across all aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies.
  • Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations.
  • Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests.
  • Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities.
  • Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution.
  • Provide technical guidance on post-approval changes and lifecycle management strategies.
  • Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently.

Requirements

  • Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline
  • 8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products
  • Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies.
  • Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations.
  • Demonstrated success authoring drug product BLA sections and supporting regulatory interactions.
  • Direct experience working with CDMOs and leading external manufacturing operations.
  • Proven people leader who develops talent and empowers teams.
  • Demonstrates strong cross-functional leadership with the ability to navigate ambiguity and drive results in complex, fast-paced environments.
  • Excellent written and verbal communication skill
Benefits
  • HIGHLY COMPETITIVE SALARIES
  • ANNUAL PERFORMANCE/MERIT REVIEWS
  • ANNUAL PERFORMANCE BONUSES
  • EQUITY
  • SPECIAL RECOGNITION
  • FULLY REMOTE WORK ENVIRONMENT
  • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
  • HOLIDAYS – In 2026 we will observe 14 holidays
  • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
  • HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
  • HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
  • ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
  • LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
  • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
drug product developmentmanufacturingformulationaseptic processingclinical in-use studiesregulatory filingsBLA authoringlifecycle managementcGMPICH guidelines
Soft Skills
technical leadershipcross-functional leadershippeople developmentempowermentcommunicationdecision-makingnavigating ambiguitydriving resultsteam alignmenttalent development
Certifications
PhDMSBS