Head of Process Development

Location
South San Francisco, California, United States
Posted
Jun 15, 2021
Ref
1432324740
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 Process Development, reporting directly to the executive team, to lead a multi-functional team developing innovative gene modified allogeneic cell therapies. This role will be responsible for pre-clinical development, IND enabling studies, and technology transfer to manufacturing, including management of Cell Process Development, Vector Process Development, and Process Science teams. A successful candidate will have extensive experience with cell/gene therapy process development, deep expertise on the underlying science and technology, detailed understanding of CMC requirement for IND filings, proven people leadership skills, and the energy and boldness to grow an innovative organization.

Responsibilities
    • Process development and CMC leadership for all Senti cell therapy programs
    • Oversee all process development personnel and activities, including allogeneic cells, viral vectors, and technology development
    • Play a key role in project team meetings and decisions working closely with other functions such as Research, Clinical, Finance, Program Management, Business Development, and others
    • Prepare and present to leadership and external stakeholders on process development strategy, latest data and conclusions, plans and roadmap
    • Executes on IND development timelines against operational plan
    • Builds a team, provides necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
    • Supports technology transfer of products and processes in to the GMP facility, and serves as a key SME with external manufacturing organizations and key vendors
    • 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


Qualifications
    • Bachelor's degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 8 years of experience managing a technical team in the biotechnology or biologics industry.
    • Direct experience with cell and gene therapy process development, IND filing, and supporting clinical products
    • At least 4 years managing a process development or multi-functional technical team
    • Deep knowledge of FDA regulatory requirements for drug products and IND filing
    • Knowledgeable of GMP processes and technology transfer


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.