Head of Manufacturing, Cellular Therapies

Location
South San Francisco, California, United States
Posted
May 23, 2021
Ref
1539640549
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the "intelligence" of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.

At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

Senti Bio is seeking a Head of Manufacturing, reporting directly to the executive team, to lead an innovative allogeneic cell therapy GMP facility in the San Francisco East Bay area. This role will play a foundational role in establishing a facility and operations to accelerate and scale clinical development of Senti's novel gene modified cell therapy products from Phase 1 trials through commercial launch. A successful candidate will have extensive experience with cell/gene therapy clinical manufacturing, GMP requirements, people leadership, and the energy and boldness to grow an innovative early stage organization.

Responsibilities
    • Manufacturing site leadership (SF East Bay): make key decisions on site layout, operations, facility, personnel, and future expansion strategy
    • Oversee all GMP manufacturing personnel and activities
    • Management of the MFG budget with ability to forecast/track facility and MFG costs
    • Play a key role in facility design, capital projects, commissioning, and validation
    • Work closely with QA/QC to ensure high performance of process and product
    • Executes production and resource schedule against operational plan
    • Completes the final review of completed manufacturing documentation per compliance standards and established timelines
    • Builds a team, provides necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
    • Oversee technology transfer of products and processes in to the GMP facility
    • Develop policies and strategies for GMP manufacturing operations and expansion
    • Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
    • Interacts with outside vendors and senior management
    • Participates in multi-functional project teams, as necessary
    • Takes corrective action to bring about required changes using change control procedures
    • Willingness to travel up to 20% (between Senti facilities)


Qualifications
    • Bachelor's degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 12 years of experience managing a manufacturing team in the biotechnology or biologics industry.
    • Highly experienced with cGMP manufacturing of clinical therapeutics
    • Direct experience with cell and gene therapy GMP manufacturing
    • Managed a GMP facility (preferably cell/gene therapy) through design and commissioning
    • Deep knowledge of FDA regulatory requirements for drug products
    • Technical knowledge of cell/gene therapy processes


Salary and Benefits
    • Competitive compensation package and title commensurate with qualifications and experience in the San Francisco Biotech market.
    • Significant growth opportunity as the company expands


Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of "smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, Intel Capital, Ridgeback Capital, Lux Capital, KB Investment, Pear VC, Smilegate Investment, Menlo Ventures, LifeSci Venture Partners, Alexandria Venture Investments, Allen & Company, LifeForce Capital, Omega Funds, Nest.Bio, Gaingels, Noveus Capital, and Goodman Capital among our investors. Senti Bio is based in South San Francisco, CA, USA.