Associate Director, GMP Facilities / Mat Mgmt / Operations at Senti Biosciences
Alameda, CA, US
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
 
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.
 
We are seeking a dynamic and experienced leader:
 
1)     To oversee the full project lifecycle for our new GMP cell and gene therapy facility construction: from detailed design, implementation, construction, EMPQ, CQV to delivery of an operational facility; while in parallel, scaling up GMP Facilities team for seamless transition to post-delivery facility operations.
2)     To oversee the management of Supply Chain operations, which  includes but not limited to: GMP Warehouse Management, Purchasing, Logistics, Shipping, Receiving, GMP Inventory management, establishing GMP policies and procedures for the warehouse and installing a continuous improvement culture that supports process excellence in a dynamic environment.
3)     To oversee the development of Senti’s GMP operational scheduling / planning capabilities

Responsibilities

    • Provide oversight of the key project deliverables involving Design, Construction Oversight, CQV, and MFG Operational Readiness.
    • Provide experienced project controls oversight of the capital project through regular review of change requests, schedule, accurate cost and cash flow projections, risk management, project monthly reporting and financial audit preparation.
    • Support the management/ approval of project contracts, budgets, bid assessments, project cash flows, and budget dashboards.
    • Participate in the execution of project risk assessments.
    • Support the development of the Facility Commissioning and Validation Master Plans for the project including the design, planning, execution, review and final sign-off of CQV protocols.
    • Review P&IDs, perform P&ID walk-downs, assist with IQ, OQ and PQ efforts as required.
    • Identify project gaps and facilitate remediation plans.
    • Partner with the User Team Lead to establish and maintain the projects Master Equipment/ System List.
    • Collaborate with the project manager and external partners to develop the Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3's, Bid Assessments, and Risk Assessments.
    • Apply Quality by Design principles, experience which aligns with FDA, ICH, and ISPE guidelines.
    • Establish facilities contracts to support painting, roof repair, welding, machine shop, electrical, office moves, pest control, security, and janitorial.
    • Establish/ maintain HEPA certification program within an SOP and compliant service contract.
    • Evaluate/ establish facilities, utilities, and HVAC equipment spare parts requirements & systems to ensure required like-for-like spare parts are on hand to support facility uptime.
    • Ensure central utility plant, electrical/ UPS systems, HVAC Systems, and HEPA certifications are maintained per preventative maintenance program.
    • Support asset classification and perform criticality assessments, rating equipment criticality and assigning appropriate maintenance plans based on criticality rating.
    • Develop and integrate Work Plans associated with each piece of equipment to ensure plans will be consistently executed and documented regardless of technician.
    • Partner with operational teams to Perform Failure Mode Event Analysis (FMEA) and Root Cause Analysis (RCA) on manufacturing equipment and revision of preventative maintenance SOPs to reflect FMEA findings.
    • Assure that the construction project and the finished facility are compliant with all applicable safety, regulatory, legal requirements.
    • Lead the design and implementation of supply chain processes and systems as they relate to the successful startup, commissioning and on-going operations of the GMP CGT facility including but not limited to: receiving, warehouse management, inventory control, materials management, and logistics.
    • Serve as the subject matter expert (SME) for Supply Chain Management as required during regulatory inspections.
    • Ensure material availability to support manufacturing operations.
    • Build from the ground-up Senti’s scheduling and short-term planning capabilities: team / systems / tools / processes for evaluation of inputs and resource requirements for clinical and commercial manufacturing
    • Create and maintain detailed site plans for operations, which include: apheresis/PBMC receipt, material kitting, process intermediates, manufacturing, QC testing, QA release, drug product shipments, maintenance, shutdowns, and support operations. 
    • Develops and executes the scheduling strategy – including working with key stakeholders to determine needs and priorities.
    • Provide guidance and subject matter expertise on necessary scheduling systems.
    • Create scenario plans to accommodate required manufacturing batches and support work that is planned.
    • Develop and implement KPI and reporting capabilities.
    • Ensure a clean, safe and GMP compliant operations at all times.
    • Ensure compliance with all current federal, state and local regulations.
    • Hire and develop an engaged and high-performing team Facilities, MM and scheduling teams.

Qualifications

    • 10+ years of biotech/GCT Facilities, Supply Chain, Manufacturing, Operations, or a combination thereof.
    • Significant biopharmaceutical construction project management skills and proven experience in managing large capital projects with emphasis on CGT Projects, as well as site utility and infrastructure upgrades.
    • 5+ years of CGT/biotech design, CQV, process equipment, utility, PM, calibration, capital project management, cGMP environments and regulations experience required.
    • Previous experience in cell and gene therapy is required
    • Ability to influence across stakeholders and company functional areas to deliver creative solutions. Knowledge or experience in Biopharma facility technical operations including asset maintenance, calibration programs, and reliability programs.
    • Possess operational cleanroom design/ operations, process equipment, utilities, facilities, PM, Calibration, validation, & scheduling experience
    • A strong practical knowledge of process equipment and the technologies related to GMP cell & gene therapy, or cell culture manufacturing technology.
    • Experience in directing the design and construction of major office, laboratory and process manufacturing buildings including design, procurement and contracts, including experience in the negotiations and structures of contracts and major agreements.
    • Strong seasoned background in Project Management and understanding in the planning, design, procurement, scheduling, execution and closure of projects.
    • Experience with the design and implementation of ERP systems, with a focus on Material Management and Inventory Control modules.
    • Bachelor's degree in Science, Engineering, or similar degree preferred. Certification in Facilities Management is required. APICS certification is a plus.
    • Must possess strong ability to negotiate and influence others internally and externally.
    • Ability to work flexible work schedules.
    • Excellent computer, verbal, and written communication skills.
    • Possess and demonstrate exceptional problem-solving skills.
    • Proven ability to work in a lean organization and creatively tackle problems.
    • Work independently in a matrix environment and manage multiple tasks simultaneously.
    • Experience with health authority regulatory inspections. Experience with FDA and EU is required..

Salary and Benefits

      • Base pay and stock options to be determined based on application qualifications with the aim of being competitive with similar roles in the area
      • Significant growth opportunity as the company expands
 
Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of “smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, Intel Capital, Ridgeback Capital, Lux Capital, KB Investment, Pear VC, Smilegate Investment, Menlo Ventures, LifeSci Venture Partners, Alexandria Venture Investments, Allen & Company, LifeForce Capital, Omega Funds, Nest.Bio, Gaingels, Noveus Capital, and Goodman Capital among our investors. Senti Bio is based in South San Francisco, CA, USA.