VP, Product Development

CellFE

Alameda, CA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 02/14/2021
  • Website: www.cellfebiotech.com
  • Company Address: , San Carlos, California

About CellFE

CellFE is a cell engineering startup that enables development and manufacturing of the new generation of medicines – cell therapies. CellFE has developed a unique microfluidic platform to solve one of the most pressing issues of therapeutic cell engineering –efficiently delivering gene-editing molecules into cells while preserving cell viability.

Job Description

CellFE is a venture-backed company with a mission to make advanced therapies accessible to all by transforming the way gene therapies are manufactured. The company uses a microfluidics-based cell engineering platform that can be adapted universally to enable low-cost, high-yield manufacturing of gene therapies at scale. CellFE's first generation of products is being developed for contract manufacturers and pharmaceutical companies that specialize in ex-vivo cell therapy and viral vector ("VV") manufacturing. Our values guide our work: There is a way, Pull together, and Hard work.

 

Position Summary: The VP of Product Development is responsible for building the product development team/function from the ground up and leading customer-specific product development initiatives.

 

A successful VP of product development will

  • ensure the development of cell therapy instrument by external suppliers
  • lead the development team to effectively translate the developments from the cell therapy instrument into VV manufacturing product line to shorten the developmental timeline and build VV instrument

 

This position is based in Alameda, CA and is a member of the Leadership Team, reporting to the CEO.

 

Specific Responsibilities:

  • Partners with customers to define specifications for VV manufacturing product that fit to each customer's unique workflow requirements, and pilots the transfection system at customer sites
  • Collaborates with the internal microfluidics engineering team to conduct feasibility studies to assess and mitigate the product development risks, as well as, design high volume flow elements
  • Takes an innovative approach in the design and building of VV instruments to meet customer specifications
  • Hires and leads product development team
  • Trains, coaches and mentors the team in functionally related topics
  • Ensures that the product team effectively translates the development of cell therapy instrument into VV manufacturing product line and meet timelines
  • Defines scope, sets timelines, and mitigates gap/risks of the projects. Prioritizes resources as needed to achieve corporate and department goals
  • Oversees manufacturing and quality control functions
  • Appropriately implements quality management systems established within the organization
  • Prepares materials and presents at Board of Directors and Investor meetings, as required

 

Qualifications:

  • Minimum of bachelor's degree and 15+ years of progressive medical device/lab equipment development work experience, or an equivalent combination of education and work experience
  • Successful track record of leading technical teams of 10+ people to develop products from bench/initiation to final product/product launch, under aggressive timelines
  • Experience building effective and high performing teams from the ground-up, including recruitment and development of talent
  • Experience developing products for evolving/novel customer workflows
  • Prior project management experience
  • Demonstrated success at working with customers from large, established companies
  • Experience developing modular/customizable systems
  • Experience developing fluid-handling products
  • Familiarity with Pharmaceutical/CDMO manufacturing process
  • Experience in budget management
  • Experience with process validation (IQ/OQ/PQ)
  • Strong knowledge of GMPs, GDPs, ISO 13485/9001, ISO 14971 and 21 CFR 820
  • Managing external suppliers/vendors to deliver on time and within the budget

 

Competencies:

  • Good at figuring out the process necessary to get things done (including organizing people) and leveraging resources effectively
  • Can design practices, processes and procedures to ensure clear outcomes
  • Strong customer focus
  • Ability to hold people accountable; sets clear objectives and provides on-going feedback
  • Ability to attract and hire top industry talent
  • Comfortable with and capable of working in an early-stage environment without a lot of infrastructure and guidance
  • Passionate about CellFE's vision, mission and values

CellFE is an equal opportunity employer

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.