Senior Manager, Drug Product Manufacturing

GondolaBio Formulator Position

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are

We are seeking an experienced and talented formulator to lead drug product manufacturing activities for oral small molecule programs. This individual will lead drug pre-formulation assessment, product formulation development, process development, physical characterization of intermediates/final drug product, and engineering/scale up/registrational stability batches manufacturing at CDMOs. The ideal candidate is a strong formulator with experience in end to end formulation drug product development, characterization, scale-up, and external partner management.

Key Responsibilities

• Lead late-stage drug product manufacturing activities for oral small molecule programs.
• Provide technical oversight for spray-dried dispersion (SDD) intermediate and tablet dosage form processes.
• Serve as "person-in-plant" at CDMOs during process characterization, engineering, registration, and validation batches.
• Drive process understanding and execute risk-based process characterization studies to support control strategy development.
• Manage execution of registration stability batches in support of global regulatory filings.
• Oversee process validation activities, ensuring compliance with ICH and cGMP standards.
• Partner with internal CMC, quality, and regulatory teams to author/review CMC sections of regulatory submissions (NDA/MAA).
• Identify and mitigate risks to supply, quality, and timelines in the drug product manufacturing process.
• Ensure efficient tech transfer and scalability of drug product processes across sites and vendors.
• Manage relationships with CROs/CDMOs, ensuring high-quality execution of deliverables.

Preferred Education & Experience

• B.S./M.S. in Chemical Engineering, Pharmaceutics, Industrial Pharmacy, or related discipline; Ph.D. preferred.
• 7+ years of industry experience in drug product process development and manufacturing, with significant late-stage experience.
• Deep technical knowledge of solid oral dosage form development and scale-up, ideally with spray-dried dispersion intermediates and tablets.
• Hands-on experience with process characterization, control strategy development, and validation.
• Strong experience leading registration stability and validation campaigns at CDMOs.
• Proven track record as "person-in-plant" ensuring technical success during late-stage and commercial campaigns.
• Familiarity with global regulatory expectations for drug product process validation and filings.
• Excellent communication, leadership, and project management skills.
• Comfortable operating in a small biotech environment with a high degree of ownership and visibility.
• Thrives in a fast-paced, entrepreneurial environment with a hands-on approach
• Up to 20% travel may be required.
• Excellent communication skills with both technical and business stakeholders
• Strong organizational and problem-solving abilities in fast-paced environments

No Matter Your Role At GondolaBio, Successful Team Members Are

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

What We Offer

• 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

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.

The base pay range for this position is $186,000 to $205,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.