Vice President, Analytical Development, Quality Control
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Job Description
Vice President of Analytical Development & Quality Control at CG Oncology focusing on advancing bladder cancer immunotherapies through strategic leadership and compliant operations.
Responsibilities:
- Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies.
- Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions.
- Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway.
- Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company.
- Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management.
- Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations.
- Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product.
- Lead and scale Quality Control operations, including in-house and external QC testing activities.
- Ensure QC systems meet GMP requirements and remain inspection-ready.
- Support regulatory submissions and serve as an analytical SME for health authority interactions.
- Build, lead, and mentor a high-performing Analytical Development and Quality Control organization.
- Manage external laboratories, CROs, CDMOs, and testing partners.
- Collaborate cross-functionally to support tech transfer and commercialization readiness.
Requirements:
- PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline.
- 15+ years of experience in analytical development and/or quality control in biotech or pharma.
- Experience supporting late-stage clinical programs, BLA submissions, and commercial readiness.
- Deep knowledge of GMP, ICH guidelines, and global regulatory expectations.
- Proven experience leading and scaling analytical and QC organizations
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 2025 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
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