StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.
We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.
Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio's offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC, within 10 miles of downtown Durham and Raleigh-Durham International Airport. Please visit www.stridebio.com to learn more.
As our new Facilities Supervisor, be one of the first team members in Technical Operations reporting into and partnering with our Senior Director. You will support the overall GMP operations for a Phase I/II GMP biopharma manufacturing facility as we build out. You will perform and oversee the general and preventative maintenance of the new manufacturing facility, and will also have the opportunity to help select and manage 6 facilities staff.
Oversees the operation, inspection, and repairs to all building operating systems including boilers, chillers, cold rooms, heating hot water, chilled water, air handlers, HVAC, electrical, compressors, emergency generators, fire/life safety, DI Water systems, waste, landscaping, and plumbing. Read and interpret equipment manuals and work orders to coordinate required maintenance and service.
Obtain bids and manage service agreements for additional maintenance and ensure adherence to specifications.
Oversee maintenance of permit requirements (i.e. elevator, escalator, alarms, etc.).
Supervise food service equipment maintenance including dishwashers and refrigeration units.
Train, supervise and evaluate departmental staff and service providers. Plan and execute work schedules.
Supervise third party service providers by enforcing the agreed-upon scope of services within the various signed service agreements.
Develop and review work schedules for maintenance staff to ensure efficient staffing.
Detect faulty operations, defective material, and reports these and any unusual situations to management.
Develop metrics for reporting performance of the department.
Comply with safety regulations and ensure that all areas are maintained clean and orderly.
Supervise mechanics who specialize in troubleshooting and repairing general building operating systems. This equipment includes AHUs, refrigeration systems, various utility systems (stated above) and basic controlled temperature units (TCUs) such as incubators, freezers, and refrigerators.
Assist in establishing/maintaining preventative maintenance programs for the utility equipment and CTUs; this includes generating preventative maintenance SOPs/records for various equipment (manufacturing/lab), change control, and facility quarantines.
Initiate/complete various types of GMP documentation such as change control, deviations, ICARs.
Work with laboratory/manufacturing staff and subcontractors on scheduled equipment preventative maintenance and equipment repairs.
Accurately maintain/complete all equipment logbooks and maintenance records within a software maintenance management program.
Will assist as needed in other facilities groups such as metrology and the bioprocess facilities group.
Participate in facility expansion and validation.
Troubleshoot/repair equipment throughout the mechanical rooms and at times, laboratories, clean rooms, and administration areas.
Install/repair/perform preventative maintenance on HVAC systems, boilers, chillers, process gas systems, purified water skids, clean steam generators, autoclaves, and other various facility equipment to accomplish company goals.
Work with automation and controls engineering design, repairs, and maintenance.
8+ years of related experience (GMP/Biotech & Biopharma maintenance/engineering)
Significant experience working in a cGMP regulated environment.
Experience working with AHUs, refrigeration systems, various utility systems (HVAC systems, boilers, chillers, process gas systems, purified water skids, clean steam generators, autoclaves, etc.) and/or basic controlled temperature units (TCUs) such as incubators, freezers, and refrigerators.
Must have a thorough knowledge of major building systems, HVAC, electrical, plumbing, and mechanical systems.
Prior supervisory experience.
Experience managing BMS and EMS systems.
Proven project management skills.
Good written and verbal communications and interpersonal skills; ability to interact with all levels.
Proven self-starter who sets aggressive goals and consistently gets results.
Ability to thrive in a fast-paced environment with multiple projects and deadlines.
Excellent business judgment, problem-solving and decision-making abilities; proven ability to think outside of the box and innovate.
Experience in the biotech and/or pharmaceutical industry.
Ability to read and interpret engineering (mechanical/electrical/P&ID) drawings and specifications.
Experience with AAV or vector manufacturing facility design
Facility start-up experience
Ability to move 75 lbs. required.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands; reach with hands and arms; climb or balance; stoop, kneel, crouch or crawl.
Must be able to perform repetitive motion activities for long periods of time.
Must be able to stand for long periods of time.
COMPENSATION & BENEFITS:
We offer a competitive salary and excellent benefits package including:
Stock Options and Bonus
Medical, Dental, and Vision health insurance
Matching 401k plans (both Pre-tax and Roth Post-tax)
Life/AD&D, Long-term and Short-term disability
Employee Assistance Program
Voluntary: Supplemental Life, Critical Illness, Group Accident, Hospital Indemnity, Identity Theft Protection
Additionally, we provide the following perks:
Retail Member Discount Programs
Complimentary onsite gym membership
Fully stocked kitchen
Socials, happy hours, and other events throughout the year (currently "virtual")
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.