VP, Product Development

Employer
CellFE
Location
Alameda, CA
Salary
DOE
Posted
Jan 26, 2021
Ref
1636221
Discipline
Administration, General
Required Education
Bachelors Degree
Position Type
Full time

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


For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/1636221-501880