Manufacturing Manager

Manufacturing Manager

CELL THERAPY

Natick, MA • Full Time

HebeCell Corp is a biotechnology company focused on translating cutting-edge stem cell technologies into novel cell therapies. Our team of researchers include world-leading experts in stem cell biology, as well as experienced entrepreneurs and business developers.

Since 2016, we have grown HebeCell into a leading innovator in the field. HebeCell has recently raised $53 Million in Series A Financing to Advance its Unique Off-The-Shelf PSC-CAR-NK product into the clinic, targeting cancers, autoimmune and infectious diseases. We are primarily engaged in developing universal and cost-effective NK cell therapeutics based on its proprietary 3D-pluripotent stem cell (PSC) platform, the off-the-shelf NK cell products will be readily available to all patients worldwide. We have developed and patented a method of producing allogeneic natural killer (NK) cells indefinitely from induced pluripotent stem cells (iPS cells) by suspending them in a liquid solution within specially engineered bioreactors. No other company or lab has this technology or these capabilities.

Currently HebeCell is looking for a cell therapy leader with GMP manufacturing expertise to serve as Manager of Clinical Cell Therapy Manufacturing. This is an exciting opportunity to join HebeCell and be a part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific thoroughness, entrepreneurial mindset, and ability to function in a complex environment are essential.

Key Responsibilities:

The primary accountability of this role is to enable the manufacturing of cell therapy products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing suite in Natick, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.

Specifically:

  • Provide leadership to oversee the operation of a GMP cell therapy manufacturing operations
  • Manage operational staff, including developing staff capabilities through initial and ongoing training and maintaining team
  • Provide management oversight of tech transfer
  • Provide management oversight of drug products
  • Manage the production schedule and the daily tasks of the Manufacturing
  • Provide oversight and guidance related to training materials, SOPs, batch records, reports, risk assessments, materials management,
  • Work cross-functionally with process development, quality, and other counterparts for the development of next-generation cGMP cell therapy manufacturing
  • Works closely with senior management to initiate new projects and assist in developing processes/techniques to meet business

Basic Qualifications:

  • Bachelor’s degree in sciences or engineering discipline with a minimum of 8 years of industry experience or a Master’s degree with a minimum of 4 years of industry
  • Experience in managing direct reports or project
  • Experience with GMP regulations and cell
  • Experience in GMP documentation and
  • Ability to operate and thrive in a fast-paced, high-growth
  • Strong skills in change
  • Excellent communication
  • An ideal candidate would have direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy.
  • Involvement in delivering a cell therapy-based product into clinical
  • Flexibility in working schedule to accommodate weekend work if necessary
  • Authorized to legally work in the

HebeCell Corp offers comprehensive employee benefits including medical, dental and vision insurance, matching 401(k) contributions, performance bonus, paid vacation, holidays and sick leave, life insurance, disability benefits and free workday lunch etc. Employee may be eligible for company stock option plan.

Position and compensation will be commensurate with experience.

To apply, please submit your cover letter/ resume to: info@hebecell.com