Associate​/Director, Drug Substance Manufacturing

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Associate/ Director, Drug Substance Manufacturing

Associate/ Director, Drug Substance Manufacturing Palo Alto, CA

Gondola Bio is a clinical‑stage biopharmaceutical company focused on developing next‑generation therapeutics for genetic diseases. Originally launched as Bridge

BioX, a subsidiary of Bridge Bio, Gondola Bio secured $300M in private financing from external investors in 2024 and became an independent company within the Bridge Bio ecosystem. The company aims to leverage cutting‑edge biological research to create breakthrough medicines addressing high unmet needs across multiple therapeutic areas, including neurology, pulmonology, cardiology, nephrology, and endocrinology. Located on the Stanford Life Sciences campus, Gondola Bio fosters a unique hybrid environment where top scientists from around the world collaborate with senior leadership and advisors, blending industry expertise with academic innovation.

The Associate Director/Director Drug Substance Manufacturing will report directly to the Executive Director CMC and will oversee Drug Substance Development and Manufacturing working closely with outside labs. This individual will also be responsible for authoring relevant sections of regulatory submissions using appropriate scientific data and will be involved in overall document review. The individual will also be responsible for development of chemical processes for active pharmaceutical ingredients (APIs) as well as starting materials, process scale‑up, technology transfer and validation of chemical processes.

Effective management of CROs and CMOs will be a crucial strategy and activity required to accomplish the functions mentioned.

• Lead process development and supply chain of small molecule and peptide drug substance activities for all phases of clinical development and commercialization.
• Review and approve master as well as executed batch records from all manufacturing activities and lead key process problem resolution activities and process improvement initiatives.
• Write and review relevant sections of IMPD/IND to support regulatory filings.
• Extract scientific data and provide appropriate document review to support regulatory filings and commercialization on time.
• Manage multiple CMOs/CROs to deliver API and intermediates of sufficient quality and quantity to meet regulatory requirements and corporate objectives.
• Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch. Ensure that all chemical processes are developed to deliver company targets of cost, quality, safety, environmental, and operability needs.
• Work closely with QA to develop and operate appropriate procedures (SOPs), specifications and ensure the product meets established quality standards.

• PhD in Organic chemistry with 10+ years of process development, manufacturing and tech transfer experience in the pharmaceutical industry.
• In depth knowledge of cGMP practices, with extensive experience in developing scalable methodologies for small molecules.
• Strong knowledge of US FDA, EMEA and ICH guidelines is a must.
• Excellent scientific knowledge in organic chemistry [DS1]
• Experience in managing CROs and CDMOs.
• Experience in drafting relevant sections IND/IMPD and NDAs to support regulatory filings.
• Experience in drafting, reviewing and submitting required documentation pertaining to the cGMP and GLP environment.
• Effective verbal and written communication skills
• Ability and track record of successfully working in cross‑functional teams to progress projects as a representative Analytical function.
• Ability to navigate and be successful in a fast‑paced work environment.
• A desire to be part of a highly innovative company aimed at helping patients with serious diseases.
• All candidates are expected to have authorization to work in the United States
• This position may require limited collaboration with and supervision of contractors external to the company.
• Travel – up to 20% may be required