Facilities Manager

Location: West Sacramento, CA

Company Profile

Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life- enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing.

GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

Position Summary

The Facilities Manager will hire, develop, and effectively manage the performance of Facilities Associates to accomplish all business objectives. Lastly, the Facilities Manager is responsible for the management and oversight of all external vendors (e.g., equipment maintenance, service contracts, etc.), as well as well as managing facility operations within assigned annual budget.

• Develop, implement, and modify programs to maintain the physical plant, grounds and equipment through effective utilization of personnel, materials, and systems (e.g., CMMS).
• Plan and implement preventative maintenance programs for the physical plant, grounds and equipment, including HVAC, MEP, cold storage, process equipment, water system(s), etc.
• Monitor the building and physical plant to ensure safety, proper operation and compliance with all state, federal, and accrediting agencies.
• Conducts and documents regular facilities inspections to ensure compliance with applicable regulations and certifications (e.g., ISO 13485, ISO classified space requirements, etc.).
• Identifies, contracts with, and manages all external service vendors, as well as checks completed work by vendors and contractors.
• Ensures that the facility is clean and maintained according to company policy and procedures and in compliance with ISO 13485 and appropriate cGMP requirements.
• Responsible for planning and implementing facility improvements and upfits, as well as planning and implementing solutions to workflow bottlenecks.
• Collaborate with EH&S team to optimize work environment safety and proactively consider all Facilities responsibilities from an EH&S perspective.
• Creating and revising documents related to Facilities and EH&S Department.

• Customer Centric
• Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
• Effective Teamwork
• - Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of teams.
• Personal Leadership
• - Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
• Planning and Organizing
• - Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.
• Effective Communications
• - Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.

• Team Leadership
• Expert at building, organizing, and managing diverse teams to accomplish challenging objectives – on time and under budget. Takes proactive steps to design and implement systems to effectively communicate team vision/ mission and cultivates the motivational atmosphere required to maximize the performance of everyone within the team.
• Execution Management
• - Expert at deploying tools and processes to bring clarity – and accountability – to the complex actions and deliverables required to accomplish the objective. Ruthlessly manages project deliverables, timelines, and results. Holds individuals and teams accountable to deliver on commitments.
• Performance Management
• - Sets objectives and metrics with individuals and teams to ensure clarity regarding the desired outcomes and how success will be determined. Skillful in coaching – and supporting – individuals and teams. Able to quickly identify performance gaps, assess root cases, and implement corrective actions. Unsatisfied with poor performance and able to rigorously address performance barriers.
• Business Acumen
• - Keen ability to understand how a business works, how the business delivers value to customers, how it makes money, and how strategies and decisions impact financial, operational, and sales results. Able to quickly understand the nuances and trade-offs associated with critical business issues, challenges, and opportunities, and make decisions that generate the greatest benefit to the business – and stakeholders.

• Integrity
• Doing the right thing – the first time. Honoring and keeping commitments.
• Intensity
• - Working with speed and focus to deliver the highest quality results – on time.
• Involvement
• - Embracing unique perspectives and treating others with dignity and respect.
• Innovation
• - Biased to improve processes and products to better serve customers and improve workflows.

• BA/BS degree in Engineering, Biological Sciences, and/or related discipline or equivalent practical experience
• Knowledge of engineering, plant operations methods, techniques, and maintenance.
• Experience in a rapidly evolving R&D and Biotech/Pharma environment, including knowledge of single use and stainless-steel liquid manufacturing equipment, WFI (or equivalent) water systems, process equipment such as clean in place/ steam in place, etc.
• Knowledge and familiarity with all required and pertinent city/state/regulatory codes and guidelines, including direct experience with cGMP manufacturing/ warehousing requirements such as ISO 13485, ISO 9001 : 2015, 21 CFR 820, etc.
• Experience with facility expansions, workflow planning, and space planning.
• Minimum 8 years of experience, with at least 3 years in a managerial position or equivalent.
• Direct EH&S experience, as well as Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or Certified Hazardous Materials Manager (CHMM) certifications, is a plus for this position.
• Effective interpersonal skills dealing with people in a variety of functions.
• Ability to effectively present complex topics in a concise manner.
• Experience with external auditing agencies and requirements.
• Effective oral and written communication skills