Associate Director, Facilities And Maintenance

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.

We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.

Position Background:

The position is accountable for achieving business objectives that ensure the building and equipment are maintained in a state that is fit for safe use in the production of biologics by company employees, costs containment, and work performance in a manner compliant with governing regulations and cGMP practices.

Remote Work Designation: Not Remote

Major Accountabilities:

• Develop, implement and maintain a comprehensive maintenance and facility program for the site including supporting policies and procedures
• Manage daily operations and the associated vendors supporting janitorial services, pest control, uniform services, landscaping and other facility management services
• Plan and direct capital and construction management projects with the accountability for successful completion of all project deliverables to the facility within established schedule, scope, and quality objectives
• Negotiate plans, budgets and schedules relating to facility modifications, facilities or equipment maintenance, expansions, upgrades and/or new construction
• Assist in the development of documentation, including functional requirements, design documents, test protocols, SOPs and reports
• Manage planned and reactive maintenance activities for the site such as preventative, predictive, corrective and emergency maintenance. Ensure reliability of equipment, efficient utilization of maintenance resources and contract maintenance services
• Ensures the uninterrupted delivery of reliable utilities, which include steam, electric, compressed air, process gases, chilled water, etc. to the site customers in a cost-effective manner
• Lead, provide oversite and participate as necessary in the installation, commissioning, qualification, and validation of facility and utilities systems for commercial bioprocessing
• Identify and execute upon routine reactive and preventive maintenance activities and building automation
• Partner with key stakeholders in troubleshooting of Facilities and facility equipment for technology transfer and commercial bioprocessing
• Lead all aspects of personnel management for direct reports to include developing a staffing strategy that is consistent with overall organizational needs and objectives, recruitment of appropriate team members, performance management, development and retention of team members
• Manage departmental operating budgets
• Support regulatory inspections as the subject matter expert for facility, utilities, and Maintenance.
• Support regulatory filings as required
• Conform to the compliance with federal, state, and local regulatory authorities including FDA, EMA, OSHA, EPA, for the Facilities, Utilities and Maintenance Operations
• Other duties, as assigned

Special Competencies:

• Motivate a diverse workforce, adjust communication style to get the best results from staff
• Expert understanding of advanced cGMP compliance, commissioning, qualification, and validation in a biotech/bioprocessing manufacturing environment
• Knowledge and awareness of all applicable Code of Federal Regulations
• Exhibit and radiate energy and are comfortable in a player-coach role, with a strong customer oriented approach to all business functions

General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Excellent communication and interpersonal skills
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions
• Represents the organization in a positive and professional manner
• Reports to work on time and as scheduled

Qualifications:

• BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field is required.
• At least 8 years of industry experience in facility maintenance
• Experience in the development and operation of facilities, utilities and Maintenance teams in Biotech Research, Product Development and Bioprocessing operations
• Advanced technical experience with HVAC, boilers, chillers, and generators
• Knowledge and experience with standard bioprocessing skills as well as use and Maintenance of common laboratory procedures and equipment
• Experience in mentoring staff in facilities operations and Maintenance environments
• Background in building automation with electrical and mechanical control integration within cGMP regulated facilities. Experience with Johnson Controls, Emerson Delta V and PI interface a plus
• Previous team management or leadership required
• Experience with commissioning, qualification, and validation in a cGMP environment
• Experience working with design, construction, and engineering firms
• Experience with cGMP requirements for the lifecycle maintenance of production equipment and the documentation requirements associated with a cGMP environment

Perks:

• 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 sponsorship at this time and does not accept unsolicited resumes from recruiters.**

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