Semma Therapeutics, a biotechnology company pioneering the development of a stem cell-based cure for diabetes. We are seeking an outstanding Clinical Materials Production (CMP) Facilities and Equipment Manager to join our growing team. The full-time role will be responsible for the oversight of the commissioning, start-up and maintenance of Semma’s facility for the production of cell therapy products to support Semma’s Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA).
The position reports to the Director of Clinical Materials Manufacturing Operations, will be based in Cambridge, MA (Kendall Square) and may require periodic travel to Semma’s device production laboratories in Providence, RI.
- Ensure safe and compliant daily maintenance and operation of the clinical materials production facility and equipment in support of Semma’s Phase I/II clinical trials.
- Ensure Tissue Culture, Quality Control lab and warehouse facility is operating to specification (ISO Class) and functional commitments (visitor policy, waste removal, pest control etc.)
- Work with stakeholders as the cGMP Engineering/Facility representative for start-up, commissioning, and qualification activities. Approve protocols and reports as required. Lead or execute FAT and SAT jointly with project team.
- Set up and maintain the equipment and instrument management database. Assess equipment needs and determine appropriate equipment to purchase. Set calibration ranges to meet process requirements. Work with vendors or 3rd party services to set-up initial and routine calibration and preventive maintenance.
- Point of contact to resolve equipment and facility issues to keep the production facility running and in compliance (process equipment, janitorial, mechanical systems, Environmental Monitoring, USP water, process gases, controlled access, Building Management System, etc.)
- Establish and manage the outsourced site services and contractors, such as cleanroom cleaning, pest control, chemical and hazardous waste disposal, gas tank exchange, clean room gowning and laundry, building maintenance, etc. Evaluate contractor and outsourced service performance to continually improve quality of service.
- Ensure facility cleaning, maintenance and environmental monitoring is completed as required by operating and Quality policies
- Coordinate daily schedules with operations, maintenance, and administrative staff groups to ensure proper coordination of resources
- Schedule and coordinate periodic utility shutdowns and its associated start-ups
- Perform or manage routine testing of purified water system and cleanroom air and surfaces
- Manage the engineering document control system. Write, review, and approve facilities/utilities/equipment/instrument SOPs, policies, workflows, training documents, etc., including Environmental, Health Safety (EHS) procedures in area of responsibility
- Support regulatory filings, internal audits, and inspections as required
- Serve as a liaison to senior management, cross-functional areas and external organizations such as sponsors and government agencies. Provide regular Facilities & Equipment status updates
- Provide training and guidance to other employees.
- Work within established Capex and Opex budgets. Assist with capital planning
- On call for facility emergencies
- Minimum of 10 years of experience operating and maintaining cGMP cleanroom environments or equipment.
- Experience overseeing equipment manufacturers, service vendors, construction trades, etc.
- Knowledge operating and maintaining water, HVAC, Building Management Systems.
- Familiarity with BSL-2 requirements and practices
- Ability to rapidly diagnose and remediate failures in complex systems
- Experience using and maintaining equipment databases and calibration systems
- Experience commissioning and qualifying equipment and facilities.
- Experience managing, documenting and justifying changes in a controlled and regulated environment
- Bachelor’s degree in Engineering or related discipline
- Experience in biotech or biologics
- Experience establishing or setting equipment and engineering systems and databases
Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.