Cedars-Sinai GMP Manufacturing Facilities Supervisor - Biomanufacturing Center in Los Angeles, California
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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).
As a Facilities Supervisor in our Biomanufacturing Center, you will plan, organize and schedule activities in coordination with internal stakeholders and with service providers to prepare site to a state of readiness for agency inspections and visitors. You will provide support for audits and inspections. Maintains all records as necessary to satisfy standard operating procedures (SOPs) and Good Manufacturing Practices requirements.
Primary Duties & Responsibilities:
Manages the outsourced site services (such as pest control, janitorial cleaning, laundry, waste handling, building maintenance, and landscape) and ensures compliance with cGMP. Establishes and manages contracts with external service providers. Monitors contractors, performs audits and establishes routine routes and timings for cleaning requires and pest control contractor. Ensures outsourced services report and provide documentation, and incident management and training requirements.
Interfaces with all support units to ensure the quality services are provided to support safe manufacturing operations. Establishes and operates a customer service feedback mechanism to address and timely resolution of concerns. Coordinates/schedules with operations, maintenance and administrative staff for delivery of support services.
Supervises equipment performance and makes necessary corrections. Conducts daily audits and inspections for quality and safety. Makes necessary corrections and creates and/or modifies polices and programs.
Provides appropriate and timely input to projects related to facilities and operational requirements. Manages process related capital projects. Lead and/or execute FAT, Commissioning and SAT jointly with project team.
Diagnoses and performs corrective and preventive action following mechanical systems failures. Responds to and resolves facility emergencies.
Manages surface bioburden and air (particulate) testing and routine testing of purified water system. May perform testing.
Organizes and schedules cleaning of clean rooms per programmatic requirements.
Orders and maintains supplies of facility gasses and services.
Ensures high standards and compliance of cleanliness levels as required by site standard operating procedures (SOPs). Tours areas of responsibility multiple times throughout shift.
Develops maintenance programs and cost-effective solutions to upkeep buildings, office furniture and site.
Develops and conducts training on mechanical systems standard operating procedures (SOPs).
Ensures work assignments and schedule provide adequate coverage. Trains employees and monitors new hires. Enforces department policies, follows up on daily assignments, and conducts counseling or disciplinary action.
- HS Diploma/GED is required. Bachelor's degree is preferred.
Experience & Skills:
At least six (6) years of experience and extensive knowledge of cGMP requirements for facility compliance in an academic setting.
Familiarity with and ability to control BMS for mechanical systems.
Expert knowledge of pest control, janitorial cleaning and laundry, and regulatory inspections.
Working Title: GMP Manufacturing Facilities Supervisor - Biomanufacturing Center
Department: CS Biomanufacturing Facility
Business Entity: Academic / Research
Job Category: Facilities
Job Specialty: Maintenance
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.