Senior Director, Drug Product Development

Sr. Director, Drug Product Development

Location -Palo Alto, CA 

About GondolaBio 

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. 

Position Overview:

This position will report directly to the Executive Director, CMC. The Sr. Director of Drug Product Development will provide strategic and technical leadership for drug product development across GondolaBio’s pipeline, including small molecules and oligonucleotide therapeutics (ASO and siRNA).

This individual will lead formulation development, process development, manufacturing, and scale-up of drug products from early development through late-stage clinical development. The role includes close collaboration with internal teams and external CDMOs to ensure robust drug product design, manufacturability, and regulatory compliance. The successful candidate will oversee formulation strategy, sterile manufacturing, technology transfer, and lifecycle management of drug product to support IND and NDA submissions.

Responsibilities

· Develop and execute drug product development strategies for small molecule and oligonucleotide (ASO/siRNA) programs.

· Lead formulation development, process development, and scale-up for oral and sterile drug products.

· Provide technical leadership for oligonucleotide drug product development, including ASO and siRNA formulations.

· Oversee sterile drug product processes including fill-finish operations and aseptic manufacturing.

· Manage drug product development activities at CDMOs, including formulation screening, process optimization, and technology transfer.

· Collaborate with CMC, Analytical Development, Regulatory, Quality, and Clinical teams to align development strategies.

· Design and oversee formulation, process development, and stability studies.

· Support clinical and commercial manufacturing, including process validation and lifecycle management.

· Author and review drug product sections of regulatory submissions (IND/NDA).

· Review development reports, batch records, and investigations.

· Manage CDMO relationships, timelines, budgets, and project plans.

· Mentor and manage drug product scientists and foster a collaborative team environment.

Qualifications

· Degree in pharmaceutical sciences, chemical engineering, pharmaceutics, or related discipline (advanced degree preferred). PhD with ~15+ years’ experience or equivalent industry experience.

· Extensive experience in drug product development for small molecules and/or oligonucleotide therapeutics (ASO, siRNA).

· Strong expertise in formulation development for oral solid and sterile injectable drug products.

· Experience with sterile manufacturing, aseptic processing, and fill-finish operations.

· Track record advancing programs through clinical development and regulatory submissions.

· Experience managing CDMOs and supporting technology transfer and manufacturing.

· Strong understanding of cGMP and global regulatory requirements.

· Excellent project management, leadership, and communication skills.

· Ability to work across internal teams and external partners in a fast-paced environment.

· Willingness to travel up to 20% and participate in global teleconferences as needed.

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 

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 

The base pay range for this position is $254,000 to $300,000 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.