GondolaBio

Director, CMC Process Development, Manufacturing

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

  • Develop and execute drug substance CMC strategies for synthetic oligonucleotide (ASO and siRNA) programs across all stages of development.
  • Provide scientific and technical leadership for process development, manufacturing, and scale-up, ensuring alignment with program timelines and regulatory expectations.
  • Serve as the DS subject matter expert within cross-functional program teams.
  • Lead process design and optimization for oligonucleotide drug substance manufacturing, including all the unit operation of solid-phase synthesis, deprotection and cleavage, purification (chromatography and alternative methods), concentration, desalting, and formulation-ready DS preparation
  • Define scalable manufacturing approaches and process characterization strategies.
  • Establish process control strategies, in-process controls, and critical quality attributes (CQAs).
  • Oversee external CDMO activities, including process development, GMP manufacturing, scale-up, and technology transfer.
  • Serve as the primary technical interface with CDMOs, ensuring: high-quality execution, on-time delivery, and budget and scope control
  • Review and approve development reports, batch records, manufacturing protocols, deviations, and investigations.
  • Author, review, and approve drug substance sections of regulatory submissions (IND, IMPD and NDA).
  • Support regulatory interactions related to DS manufacturing, control strategies, and comparability.
  • Ensure DS activities meet cGMP, ICH, and global regulatory requirements.
  • Lead process validation, PPQ planning, and commercial manufacturing readiness.
  • Develop and execute lifecycle management and continuous improvement strategies.
  • Support supply chain robustness and long-term manufacturing strategies.
  • Build, mentor, and manage a high-performing drug substance CMC team.
  • Foster a collaborative, science-driven culture focused on accountability, transparency, and execution excellence.
  • Provide technical coaching and career development for DS scientists and engineers.

Requirements

  • Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline (MS/BS with significant industry experience considered).
  • Typically 10+ years of industry experience in drug substance development and manufacturing.
  • Deep hands-on expertise in synthetic oligonucleotide (ASO and/or siRNA) process development.
  • Demonstrated success advancing DS programs from early development through clinical and/or commercial stages.
  • Strong experience with synthetic oligonucleotides unit operations, including solid-phase oligonucleotide synthesis, purification and downstream processing, and GMP manufacturing and technology transfer
  • Proven ability to manage external CDMOs and complex project timelines.
  • Solid understanding of cGMP, ICH guidelines, and global regulatory expectations for oligonucleotide therapeutics.
  • Excellent leadership, communication, and cross-functional collaboration skills.
  • Comfortable operating in a fast-paced, high-accountability biotech environment.
  • Willingness to travel and work across global time zones 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.
  • 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
drug substance CMC strategiesprocess developmentmanufacturingscale-upsolid-phase synthesisdeprotectioncleavagepurificationchromatographyGMP manufacturing
Soft Skills
scientific leadershiptechnical leadershipcross-functional collaborationmentoringteam managementcommunicationaccountabilitytransparencyexecution excellencecareer development