COMPANY BACKGROUND:

GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

To learn more, visit us at gondolabio.com

Who You Are:

We are seeking an experienced and strategic scientist to lead all aspects of Chemistry, Manufacturing and Controls for an early phase, small molecule program. This individual will be a key member of the development leadership team, responsible for overseeing drug substance and drug product development, supply chain, and regulatory CMC strategy from preclinical through clinical phases. The ideal candidate is hands-on, resourceful, and comfortable operating in a fast-paced, lean start-up environment. Effective management of CROs and CMOs will be a crucial strategy and activity required to accomplish the functions mentioned.

Responsibilities

• Provide overall CMC and Drug Substance leadership for an early phase, small molecule program, in a rare disease therapeutic   area

• Manage and oversee drug substance (API) and drug product (DP) development, including selection and management of CDMOs

• Develop and execute phase-appropriate manufacturing and analytical development plans

• Ensure timely and compliant delivery of clinical trial materials

• Author and review CMC sections of regulatory submissions (e.g. INDs, IMPDs, etc)

• Coordinate with Quality Assurance to implement and maintain quality systems appropriate to the stage of development

• Identify, evaluate, and manage external vendors (CMOs, CROs, consultants) to ensure high-quality and cost-effective services

• Collaborate cross functionally with nonclinical, clinical, and regulatory colleagues to align CMC activities with program milestones

• Lead risk assessment and mitigation planning for supply chain, manufacturing, and quality operations

•  Lead and develop a lean high performing CMC team as appropriate

• Create a culture of continuous improvement and high-performance teamwork

• Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls

• Continually seek and implement process development best-practice methodologies

Education, Experience & Skills Requirements

• Ph. D. with 10+ years of relevant experience, or BS/MS with 15+ years relevant experience
• Training and education in organic synthesis
• Significant project leadership experience
• Demonstrated success in leading  CMC activities from preclinical through clinical development
• Demonstrated experience in managing API chemical development and manufacturing for clinical trials
• Demonstrated chemistry  development at an industrial scale
• Proven ability to manage and  influence external partners and vendors
• Working knowledge of FDA and ICH  guidelines for INDs/NDAs/MAAs and cGMPs
• Experience in managing CMOs, scientific collaborations, and contracted R&D
• Ability to effectively manage highly skilled internal staff (direct reports)
• Strong aptitude and demonstrated  experience in synthetic organic chemistry
• Familiarity with analytical  methods development and validation
• Working knowledge of process economics
• Ability to work independently as well as in a team; ability to build good work relationships
• Strong attention to detail and  time management skills
• Excellent oral and written communication skill
• 20 % travel capability is required

What We Offer: 

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Collaborative business environment
• 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
• Excellent compensation package (Base, Performance Bonus, Equity)
• Excellent benefits package
• Flexible PTO
• Rapid career advancement for strong performers
• Work with the most productive groups of R&D operators in the industry
• A platform for meaningful scientific contributions to shine

At GondolaBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. GondolaBio is a multi-state employer, and this salary range may not reflect positions based in other states.