Vice President, Manufacturing Strategy

BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:

Finding the right starting points to target diseases at their source.

Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

Building products with world-class R&D personnel.

We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Who You Are:

The Head of Manufacturing Strategy will be responsible for developing and executing the Manufacturing strategy for the BridgeBio gene therapy portfolio and managing the portfolio lifecycle from clinical to manufacturing, regulatory approval, and launch. The incumbent will work closely with other area managers and senior management to deliver optimized strategies for the cGMP manufacture of gene therapy candidates and provide day-to-day leadership and quality oversight during the execution of cGMP campaigns for clinical and commercial supply. 

Responsibilities:

• Lead evaluation and selection of CDMOs for clinical and commercial products based on technical capability, cost, and alignment with strategic plans
• Partners effectively with CDMO’s and internal resources to develop the manufacturing strategy, regulatory strategy, operations, and other associated deliverables
• Set and implement the strategic vision to produce clinical and commercial products for the BridgeBio pipeline
• Aligns communication, accountabilities, resource capabilities, internal processes to ensure that strategic priorities yield measurable and sustainable results
• Guide the development and implementation of a portfolio of process improvements in supply environments to increase process robustness, reduce the cost of goods and increase productivity
• Provide Operational and Quality oversight of day to day CDMO activities in support of the BBGT product portfolio
• Lead troubleshooting efforts in support of cGMP investigations for OOS or other deviations
• Manage Manufacturing, Supply Chain, and Quality organizations focusing on product supply from pre-clinical development to commercialization
• Work hand in hand with Technology Transfer leads to introduce new programs and processes into manufacturing sites/CDMOs
• Develop an operational plan, budget, resourcing plan for CDMO manufacturing, works with program management to track program progress and budget
• Establish robust supply chain plans to ensure reliable clinical and commercial supply and reduce costs where possible
• Lead buildout of manufacturing operations team as needed to support the BBGT portfolio
• Lead strategic manufacturing planning including capacity analysis, CoGs, and Capex projections
• Lead planning of design and construction of commercial manufacturing facilities as required to support a growing gene therapy portfolio • Contribute to CMC sections of regulatory filings

Education, Experience & Skills Requirements:

• Bachelor’s degree in a relevant Scientific or Engineering discipline. An advanced degree is a plus.
• Minimum of 10 years of experience in cGMP manufacturing of recombinant viral gene therapy vectors, vaccines, or complex biologics
• Experience with both clinical and commercial manufacturing is required
• Previous supervisory experience is highly preferred

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
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.