Astellas Pharma Director, Operations and Facility Engineering in Seattle, Washington
Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.
Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.
Universal Cells (UCI) is announcing a Director, Operations and Facility Engineering opportunity at their facility in Seattle, WA.Purpose:
The primary purpose of the Director of Facilities and Operations is to oversee all daily operations for facility, engineering and materials management; develop operational processes, policies & procedures; and direct the daily operations of team members. Some of the essential accountabilities include: providing leadership insight on U-Cells Operations (e.g., office areas, laboratories, EHS and Material Management).
Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
Essential Job Responsibilities:
- Participates in establishing strategic plans and objectives, on administrative or operational matters and ensuring effective achievement of objectives.
- Working with the management team, develops and implements a long-range facilities plan to reach objectives, and ensures that tactical facilities decisions are consistent with this plan.
- Works with outside vendors in preparation of plans, budgets and schedules facilities modifications including estimates, quotes, layout, contracts calibrations and maintenance requirements.
- Works with outside vendors to complete inspections of construction and installation progress to ensure compliance with established specifications (including regulatory requirements from city, county, state, etc.).
- Manages engineering, maintenance, alteration and relocation of office/laboratory areas and equipment as well as space assignments and layout arrangements for new employees. Responsible for ordering and installing name plates, office/cubicle furnishing, etc., as needed.
- Maintains and monitors all building equipment including, but not limited to, HVAC, security systems, sprinkler system, utilities, and plumbing. Manages and coordinates vendors engaged in equipment installation, facilities equipment repair and preventative maintenance.
- Manages complex laboratories and assists with setting up the laboratory and coordination of the long term and day-to-day technical laboratory operations.
- Manages and updates all processes related to laboratory operations.
- Procures research materials, supplies, and manages the inventory.
- Oversees and promotes lab safety and routine laboratory hygiene.
- Maintains laboratory apparatus and equipment.
- Interacts with vendors/contractors in handling routine requests with building including electrical, and property management (i.e., building temperature, lighting, equipment failures, plumbing problems, etc.).
- Provides off-hours support during emergencies/disasters and projects requiring non-business hours supervision/coordination.
- Acts as a liaison with building property management on leasehold issues including tenant improvements, HVAC issues, etc.
- In conjunction with EH&S:
- Maintains ergonomic standards utilizing appropriate office and laboratory furnishings/equipment.
- Develops, implements and manages EH&S (environmental, health and safety) policies/procedures, benchmarks safety programs and techniques to ensure compliance, injury prevention, and risk mitigation.
- Administers office and laboratory safety and security plans and procedures, continually monitoring locations to ensure they remain safe, secure and well-maintained.
- Ensures and maintains OSHA and other regulatory compliance (environmental, health & security) in facilities and coordinates inspections. Manage agency inspections and prepare deliverables for the response to inspection reports.
- Conducts job site assessments, focusing on unsafe conditions and unsafe work behaviors; ensure appropriate action is taken to correct deficiencies.
- Performs Injury and Illness investigations, root cause analysis, data trending, program audits and laboratory safety and compliance inspections. Investigates accidents to identify their causes and find ways to prevent recurrences. Investigates, prepares, and forwards, as required, reports on injuries to appropriate agencies.
- Maintains Company OSHA/EPA hazardous waste records.
- Ensures that all required written programs (e.g., hazard communication, contingency plan, lockout/tagout, waste minimization plan, hearing conservation, blood-borne pathogens, etc.) are properly documented.
- Acts as the primary owner interface with building landlord and their site management.
- Establishes budget and accurate spending projections, manages within capital and operating resources and identifies significant capital spend requirements during budget preparation.
- Development of policies and procedures for the Facility, Operations and Engineering team; Communicates these to subordinates to ensure their compliance, utilizing proper tools and safety procedures.
- Manages and coordinates year-end shutdown to include preventative maintenance, major projects and lab modifications.
- Organizes and prepares technical documentation necessary to ensure cGMP compliance of all facilities operations.
- Develop and report metrics for continuous improvement/maintenance of the facility.
- Responsible for long-range planning and delivery of multiple change programs on time including project performance, risk management, administration, financial management and issue resolution.
- Provides managerial, strategic, and tactical leadership to team members.
- Manages all daily operations for facility, engineering and material management
- Issues and maintains security/access cards.
- Other duties as assigned.
- BA/BS degree in Engineering, from accredited institution or equivalent in related experience.
- 5-7 years' experience in engineering and/or facilities management in a corporate environment.
- Expertise with mechanical systems, HVAC systems, Certification for HEPAs, Hoods and Cleanrooms
- Demonstrated ability to form effective, high-impact partnerships with peers, leaders and internal employees as customers. Outstanding communicator, with a shown ability to use a wide variety of techniques to communicate internally to an organization. Outstanding collaborator and strong leader with demonstrated experience working collaboratively with other senior leaders to carry out programs and implement plans. Demonstrated breadth of experience in Operations and Facilities Management. Must understand facility systems and have experience working in laboratory environment.
- Strong organizational skills and high level of attention to detail; with the ability to coordinate multiple large and diverse projects simultaneously
- Ability to work a non-traditional schedule, often including evenings, weekends as needed.
- Proven capability to appropriately challenge status quo, drive and support innovation- including new ideas to streamline and enhance processes rather than solely implement current tactics;
- Strong computer skills including advanced use of Microsoft office applications
- Knowledge of equipment temperature monitoring systems, experience with Smart-Vue™ Sensors would be a plus
- Communication Skills -- Ability to effectively communicate with a varied client base including maintenance groups, service providers, project team members and management
- Leadership, project management and team building skills - Ability to lead projects and initiatives
- Team Player -- Ability to work collaboratively on various project teams
- Strong time management, organizational skills and ability to manage multiple complex technical tasks
- Ability to effectively influence cross-functionally and across multiple levels of the organization.
- Ability to work independently with minimal supervision
- Experience working in Biotech/Pharm industry
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled