GondolaBio

Vice President, CMC Analytical

GondolaBio

full-time

Posted on:

Location Type: Hybrid

Location: Palo Alto • California • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $320,000 - $364,000 per year

Job Level

Lead

About the role

  • Provide executive leadership for Analytical Development, QC, and Stability across all small molecule programs
  • Define and implement phase-appropriate analytical strategies from preclinical through commercialization
  • Build and scale analytical infrastructure, systems, and teams to support portfolio growth
  • Oversee method development, validation, transfer, and lifecycle management
  • Lead analytical and CMC strategy for global regulatory submissions, with primary accountability for NDA preparation and submission
  • Author and review Module 3 (CMC) sections, including drug substance and drug product analytical components
  • Lead responses to regulatory agencies (FDA, EMA, etc.) and represent CMC in health authority interactions
  • Ensure alignment of analytical control strategies with regulatory expectations and lifecycle management plans
  • Drive analytical activities supporting Phase 2/3 programs, registration batches, and PPQ
  • Ensure inspection readiness for pre-approval inspections (PAI) and commercial launch
  • Oversee stability programs, shelf-life justification, and comparability strategies
  • Direct and oversee multiple CMOs and CROs for analytical development, QC testing, and stability programs
  • Establish strong governance, quality oversight, and performance management frameworks
  • Lead tech transfer activities and ensure successful execution across external partners
  • Partner with Quality to ensure robust analytical QMS, including deviations, OOS/OOT, change control, and audits
  • Support internal and external audits and ensure compliance with GMP and global regulatory standards
  • Serve as a key member of the CMC leadership team, collaborating with Process Chemistry, Formulation, Regulatory, and Quality
  • Support due diligence, partnerships, and alliance management activities
  • Provide strategic input on portfolio decisions, timelines, and resource allocation

Requirements

  • Ph.D. or M.S. in Analytical Chemistry, Chemistry, Biochemistry, or related field
  • ~15+ years of industry experience in analytical chemistry within pharma/biotech
  • Significant leadership experience (Director/Sr. Director/VP level) managing teams and departments
  • Demonstrated success advancing small molecule programs from early development through Phase 3 and NDA submission
  • Deep experience in CMC regulatory strategy and authorship (IND, IMPD, NDA)
  • Proven track record of leading analytical contributions to successful regulatory filings and agency interactions
  • Extensive experience managing CMOs and global external networks
  • Strong background in analytical method development, validation, and transfer (IC guidelines)
  • Experience with a broad range of analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy, solid-state characterization)
  • Expertise in stability program design and shelf-life determination
  • Familiarity with GMP quality systems and regulatory compliance requirements
Benefits
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • A place where you own the vision for your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Commitment to Diversity, Equity & Inclusion
Applicant Tracking System Keywords

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

Hard Skills & Tools
analytical chemistrymethod developmentmethod validationanalytical transferregulatory strategyHPLCGCspectroscopystability program designshelf-life determination
Soft Skills
leadershipteam managementstrategic inputcollaborationperformance managementquality oversightgovernancecommunication
Certifications
Ph.D. in Analytical ChemistryM.S. in Analytical ChemistryPh.D. in ChemistryM.S. in ChemistryPh.D. in BiochemistryM.S. in Biochemistry