Lab Systems Manager

POSITION SUMMARY:

Reporting to the Manager R&D Laboratory, the Lab Systems Manager ensures that highly regulated laboratory, research, and manufacturing environments operate safely and efficiently. This role encompasses activities related to the maintenance and continuous improvement of R&D laboratory physical operations including instrumentation, process equipment, facilities, CO2/N2 gas supplies, cryo storage, hazardous waste disposal while maintaining strict compliance with FDA, GMP, and OSHA standards.

PRIMARY RESPONSIBILITIES AND DUTIES:

• Laboratory Instrumentation and Process Equipment: Coordinate calibration and preventive maintenance (PM) and sensitive laboratory and process equipment, maximizing work quality and minimizing downtime.  Manage instrument alarm systems and LIMBLE CMMS. Coordinate and facilitate new equipment selection. Must understand the purpose and architecture of typical laboratory instrumentation and processing equipment. Demonstrate resourcefulness and troubleshooting capability with respect to laboratory equipment.
• Lab-Specific Infrastructure: Manage specialized utilities such as DI/RO water systems, lab vacuums, process chilled water, compressed gases, and liquid nitrogen storage units.
• Building Systems: Monitor operation of and resolve building systems issues, including HVAC, electrical, plumbing, and building automation systems (BAS). Work with the Property Manager as necessary.
• Regulatory Compliance: Ensure facilities meet cGMP, ISO, and safety requirements. Lead safety audits and maintain detailed documentation for inspections.
• Environmental Health & Safety (EHS): Oversee the proper storage, labeling, and disposal of hazardous chemicals and biological materials.
• Project Management: Lead facility upgrades, lab expansions, and equipment or lab operations improvement projects, coordinating between internal research teams and external contractors.
• Vendor & Budget Management: Negotiate service contracts for specialized lab services and manage the facility’s operating and capital budgets. Interact effectively with service vendors.

QUALIFICATIONS AND SKILLS:

• Education: Bachelor’s degree or equivalent (e.g. military) in a related engineering or scientific field.
• Experience: 5–8+ years in laboratory systems management, with a strong preference for experience in highly regulated environments like biotech or pharma.
• Technical Proficiency: Knowledge of Computerized Maintenance Management Systems (CMMS) and Enterprise Resource Planning (ERP) tools. Knowledge of laboratory systems and instrumentation operating principles. Experience troubleshooting equipment and instrumentation.
• Certifications: Industry-recognized certifications such as the Certified Facility Manager (CFM) or Facility Management Professional (FMP) preferred.

About Us:

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway.  REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $90,000-$125,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

Notice to Recruiters/Staffing Agencies 

Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.