Manager, Instrumentation & Metrology

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 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.

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The Manager, Metrology & Instrumentation department is responsible for:

• 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.
• For leading the team that provides both planned and unplanned support to all pertinent functional areas as it relates to metrology and instrumentation.
• For 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…