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CG Oncology logo
CG Oncology

Attacking Bladder Cancer for a Better Tomorrow

Vice President, Analytical Development, Quality Control

Vice PresidentVice PresidentOtherRemoteLeadTeam 11-50Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

109 days ago

Salary

$310K - $335K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglish

Job Description

Vice President, Analytical Development, Quality Control

CG Oncology

• 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.

Job 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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