Manager, Instrumentation & Metrology

HUMACYTE GLOBAL INC•Durham, NC

13d•Onsite

About The Position

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 Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including 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 received the RMAT designation. For more information, visit www.Humacyte.com [http://www.humacyte.com/].

Requirements

Associate’s degree in engineering, Life Sciences or other related technical field required
7 years of applicable Metrology, Instrumentation and/or Calibration experience required
Proven leadership experience leading a team of Metrology specialists
Subject Matter Expert in metrology and instrumentation maintenance services to assure equipment reliability in manufacturing, utilities and laboratory environments
Experience with working in a clean room environment for manufacturing operations and will be required to meet applicable gowning and PPE guidelines
Required to regulatory sit; stand for prolonged periods of time. May be occasionally required to pull, life and/or move up to 20 pounds
Excellent communication and interpersonal skills.

Nice To Haves

Bachelor’s degree in electrical engineering, preferred, or equivalent training from a military environment
Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety is preferred)

Responsibilities

Oversight for Metrology Services by helping to perform calibrations, preventive maintenance activities, general repairs and troubleshooting.
Delegating tasks to team members, develop and motivate the team to achieve organizational goals and achieve targets.
Perform all aspects of personnel leadership for the metrology and instrumentation team, to include staffing strategy aligned with corporate objectives, recruitment, performance management, professional development and retention of team members.
Ensuring equipment reliability (OEE) through the development and implementation of routine preventative and predictive metrology programs.
Leading the team that provides both planned and unplanned support to all pertinent functional areas as it relates to metrology and instrumentation.
Ensuring that the Metrology department adheres to all compliance requirements.
This position will be required to be the leader in the day-to-day operations and collaborate and / or assist with the general equipment.
Ensuring observance and adherence to all safety precautions and regulations in all areas where duties are performed by team members.
Delegate and assign the day-to-day activities of the team members while motivating the team to achieve goals and KPIs.
Empowering team members with skills to improve their confidence, product knowledge, and communication skills.
Responsible for deciding how to approach tasks and develop a plan for the team to accomplish them.
Partner with Quality, Engineering and Operations groups to always ensure strict compliance with GMP/GLP guidelines, specifically to ensure that the equipment is maintained in GMP/GLP requirements.
Leads, maintains, and performs basic and advance corrective, preventative maintenance calibrations on GMP & non-GMP equipment and instruments.
Drafts all calibration procedures needed and assists in the drafting of work instructions for all process and utility equipment.
Research and provides informed recommendations for instrumentation/metrology spare parts and PM job plans.
Assists in routing all required documentation for the submittal of spare parts and PM WOs.
Subject Matter Expert (SME) to troubleshoot, test, repair and optimize instruments, equipment, and control system.
Provides I&C expertise and guidance in the Capital design, appropriation, and installation processes.
Collaborate with all depts in the continuous improvement efforts within the site Maintenance Program.
Oversee and assist in the maintenance and review of calibration standards and vendor calibration documentation.
Works with contract service providers and supports contractors executing calibration, controls and metrology activities.
Other duties as assigned.