Senior Manager, Gmp Maintenance & Calibration

JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients.  For more information, please visit our website at Senior Manager, GMP Maintenance & Calibration Position Overview: This role is responsible for the management of GMP Maintenance, Calibration and Asset Management within our GMP Manufacturing facilities.

This role will be responsible for the detailed planning of facilities and process maintenance in all ADICET BIO laboratory and GMP Manufacturing facilities. The Senior Manager will be primarily responsible for supporting the maintenance lifecycle management of laboratory, GMP process equipment, critical utilities, facility utilities, building management systems, asset management, and site infrastructure. The Senior Manager will fulfill this responsibility through proactive planning and scheduling of facility and equipment work orders, coordination with contract vendors, and documentation of work via the CMMS.

This role will also manage the MRO Stockroom and maintain the spare parts inventory program. This position works directly with Maintenance & Calibration Technicians and Engineers to ensure efficient and effective work execution. Cross-functional teamwork and communication are essential attributes as is experience working in a regulated environment.

This role will provide monthly trending and reporting of departmental KPI to upper management. Key Responsibilities: Champion safe working practices ensuring and providing safe work observations, proper controls for stored energy (lock-out, tag out), hot work permits, ensuring appropriate work PPE, hazardous materials storage and handling, spill prevention and response, proper lifting techniques, and utilizing proper tools Maintain and manage facility GMP readiness standards, including 5S program Schedule GMP maintenance, repairs and calibration program for facility, utilities, and equipment Ensure that every maintenance task performed is planned ensuring safety and quality Coordinate with service providers and technical trades Experience with lean tools, preventative and predictive maintenance concepts Interact with cross-functional teams, vendors and contractors, and report findings and proposals to appropriate stakeholders Communicate with stakeholders to define total scope of work and priority of the work to be performed Determine and outline tasks required to complete work orders Manage tasks to completion with team members Maintain training compliance to curriculum and technical knowledge to support facility equipment and systems, including basic repairs and maintenance Improve performance of facility and maximizing equipment/facility uptime Responsible for efficient and accurate physical MRO inventory transactions including, but not limited to, stocking items received, parts disbursement, returns, inventory audits and adjustments Attend routine meetings with facility management to support in the development of upcoming schedules Resolve and manage order problems such as backorders and slow shipments with outside vendors. Help schedule and expedite delivery of ordered items in conjunction with maintenance department requirements.

Together with maintenance team identify and purchase (critical) parts Identify gaps and provide content improvements to Preventative Maintenance procedures and frequency of execution using lean methodologies Manage the inventory of the stockroom and ensure parts are readily available Prepare and kit parts required for Maintenance Workorders Maintain accurate records/documentation i.e. batch certificates for parts and equipment Lead issuance and management of maintenance and calibration Purchase Orders Maintain Spares in the Computerized Maintenance Management System (CMMS) Responsible for producing monthly management reporting, data analysis and KPI reporting to facilities management Perform scheduled Cycle counts of the stockrooms Ability to develop solutions to moderately non-routine problems Vendor management skills related to facilities and maintenance Qualifications: Bachelor's degree and (6+) years of maintenance industry experience, or two-year degree in technical discipline and (8+) years of applicable experience. Flexibility given with applicable and technical expertise.

Experience working in facilities subject to GMP regulatory compliance, required Superb organizational skills, attention to detail and error-proofing habits Experience in biopharmaceutical industry, preferred Demonstrated experience working with mechanical, electrical, instrumentation and control systems Experience working with cross-functional teams Experience working with and administering Computerized Maintenance Management Systems (CMMS) e.g. Maximo, Blue Mountain, SAP Plant Maintenance or similar Experience working with process equipment (Drug Substance Manufacturing) and laboratory equipment, product use, and terminology, preferred Ability to work independently possessing strength in organizing work and time management Demonstrated ability to provide written and oral summaries of work Proficiency in working standard office applications such as Microsoft Word, PowerPoint and Excel Ability to handle competing priorities and projects, as well as urgent situations Ability to read and understand electrical, mechanical, pneumatic drawings and equipment manuals Excellent attention to detail and documentation Ability and willingness for on-call and after-hours emergencies response Ability to stand and walk throughout scheduled work shift Ability to lift and or move up to 50 lbs Ability to work in tight, low, or elevated positions Pay Range$138,000"â$192,000 USD At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match. To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave. Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms. In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions.

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.