GondolaBio

Director, Analytical Development

GondolaBio

full-time

Posted on:

Location Type: Hybrid

Location: San Francisco • California • United States

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Salary

💰 $220,000 - $250,000 per year

Job Level

Lead

About the role

  • Provide strategic leadership and technical oversight for all analytical development activities supporting synthetic oligonucleotide programs from early research through NDA approval and commercialization.
  • Define and execute analytical development strategies to address complex CMC challenges, ensuring alignment with program timelines and regulatory expectations.
  • Serve as the analytical subject matter expert across Quality Control, including scientific justification of specifications for raw materials, intermediates, drug substance, and drug product.
  • Oversee analytical method development, qualification, validation, and transfer to GMP environments, ensuring data integrity and compliance with global regulatory standards.
  • Design and oversee stability programs and analytical strategies supporting RSM designation, and overall control strategy establishment.
  • Review and approve analytical methods, protocols, reports, raw data, and regulatory documentation.
  • Lead and manage analytical activities conducted by external CDMOs, providing technical oversight, setting development targets, and ensuring timely, high-quality deliverables.
  • Partner closely with Research, Regulatory Affairs, Quality Assurance, Clinical Operations, Operations, and Business Development to proactively identify risks, dependencies, and mitigation strategies.
  • Actively participate in regulatory agency interactions and contribute to the preparation and review of INDs, NDAs, and other global submissions.
  • Develop and manage budgets, timelines, and resource plans aligned with program and organizational goals.
  • Review and approve SOPs, deviations, investigations, and change controls to ensure compliance, quality, and continuous improvement.
  • Recruit, mentor, and develop a high-performing team of analytical scientists, fostering a collaborative, accountable, and scientifically rigorous culture.

Requirements

  • Advanced degree in Analytical Chemistry or a related discipline; PhD with 5+ years of relevant industry experience strongly preferred.
  • Extensive hands-on and leadership experience in analytical method development and validation for synthetic oligonucleotides, including EX, IPRP, SEC, HILIC, 2D HPLC and other emerging technologies.
  • Demonstrated success leading analytical development programs through late-stage development, regulatory submission, and commercial launch.
  • Deep expertise in analytical control strategies across raw starting materials, drug substance, and drug product, including specification setting and justification.
  • Strong working knowledge of cGMP, cGLP, and global regulatory requirements (FDA, EMA, and other regions).
  • Proven experience interacting with regulatory authorities and contributing to successful IND and NDA submissions.
  • Experience managing external CDMOs, including technical oversight, issue resolution, and performance management.
  • Strong project management, organizational, and budgeting skills in a dynamic, matrixed environment.
  • Independent and proactive leader with excellent scientific judgment and a data-driven decision-making approach.
  • Excellent communication, mentoring, and presentation skills, with the ability to influence senior and cross-functional stakeholders.
  • Willingness to support global teams across time zones and to travel to CDMOs and CROs as needed.
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
  • An unyielding commitment to always putting patients first.
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients.
  • Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and 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
  • Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • 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 method developmentanalytical validationsynthetic oligonucleotidesEXIPRPSECHILIC2D HPLCdata integrityregulatory submissions
Soft Skills
project managementorganizational skillsleadershipcommunication skillsmentoringpresentation skillsscientific judgmentdata-driven decision makingcollaborationproblem-solving
Certifications
PhD in Analytical Chemistryadvanced degree in related discipline