Executive Director, Manufacturing

4 weeks ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob DescriptionJOB TITLE: Executive Director, Manufacturing & Supply Chain (Consumables & Raw Materials Manufacturing )

DEPARTMENT: Site Operations

LOCATION: Durham, NC, Onsite/Not Remote


COMPANY:

Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of ATEVs (acellular tissue engineered vessel), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.


JOB SUMMARY:

Humacyte is seeking an Executive Director, Manufacturing & Supply Chain to join our growing organization. The individual will serve as site head of a facility focused on cGMP manufacturing of

disposable components and media/buffer production, for use in Humacyte’s commercial manufacturing process for acellular tissue engineered vessels. The individual will be responsible for leading start-up operations of the facility and then be responsible for site operations. This is a pivotal role within an early-stage commercial company, with the unique opportunity to directly contribute to the success of the commercial program and influence the culture of the department.

ESSENTIAL RESPONSIBILITIES:

Pre-Startup and Startup Phase

  • Responsible for facility assessment, design process, and delivery of a qualified manufacturing facility.
  • Develop and implement systems and processes needed to run the site, leveraging existing Humacyte systems, but also incorporating external experiences and learning.
  • Design and develop models for capacity planning and facility utilization to support future expansion.
  • Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.

Operational Phase

  • Develop the strategic and operational plans for Manufacturing Operations and be responsible for the execution of these plans in areas of direct responsibility.
  • Develop in-depth knowledge of Humacyte’s manufacturing process and requirements for consumables and media/buffer production.
  • Responsible for staffing of the site with skilled operators who will assure high quality and consistency in production of raw materials.
  • Ensure Manufacturing Operations remain compliant with all applicable regulatory requirements. (e.g. Safety, Quality/cGMP, Environmental, Financial, Legal, HR.)
  • Ensure the site is performing at a high level with consistent delivery of product.
  • Leads supply chain and logistics functions over multiple sites, including warehouse and site logistics operations (including inventory control, shipping, receiving, inter-site transfers, GMP storage and cycle counting) and site planning and scheduling.
  • Ensure manufacturing continuity by implementing raw material safety stock strategies, and that manufacturing Bill of Materials support proper procurement of raw materials needed for product manufacturing campaigns.
  • Fosters a culture of accountability, collaboration, operational excellence and continuous improvement across all operational departments.
  • Defines and controls budget and spending, ensuring fiscal responsibility and alignment with strategic financial goals.

EXPERIENCE & QUALIFICATIONS:

  • 15+ years of operations experience in the bioprocessing or biopharma industry with a minimum of 10 years leadership experience managing teams in a cGMP environment.
  • Advanced degree (MS or PhD) in Science, Engineering or related field preferred
  • Demonstrated successful experience leading operations in a GMP Biopharma environment with experience and knowledge in Manufacturing, Supply Chain, and Facility operations
  • Experience building and developing high performing teams and ability to create strong partnerships, internally and externally
  • Experience both with early-stage commercial and established commercial organizations preferred
  • Strong ability to communicate well with cross-functional groups, including Manufacturing, MSAT and Logistics.

COMPENSATION & BENEFITS HIGHLIGHTS:

    • Stock Options
    • 401k Plan with 4% Match and no Vesting Schedule
    • Medical, Vision and Dental Plans
    • Company Paid Long Term/Short Term Disability
    • Company Paid Life Insurance
    • 23 Days Paid Time Off (PTO)
    • 10 Company Designated Holidays + 2 Floating Holidays
    • Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.

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