Senior Manager, Facilities and Engineering

at  Amplifybio LLC

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify’s Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify’s Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify’s Manufacturing Enablement Center.
About ADOC South San Francisco, CA. AmplifyBio’s discovery optimization and characterization unit (ADOC) establishes critical product characterization benchmarks, optimizes efficacy, and identifies new targets and strategies for clients preparing to scale up the production of therapeutic candidates. The site also houses GMP manufacturing suites, and quality labs available to clients. Based on broad experience in cell and gene therapy manufacturing, this group seeks to address the widening gap between R&D and manufacturing CMC.
AmplifyBio is seeking to hire a Senior Manager, Facilities and Engineering to join our growing team!!! This position reports to the Director, Engineering
The ideal candidate is an experienced Facilities professional with a track record of success managing GMP environments who understands biologics processes (i.e. cell & gene therapy, aseptic environments, reagent control, contamination control).

The candidate will be responsible for the following in support of maintaining the highest quality products:

• Manage daily Facilities, operations, risk management, and staff at the Amplify Bio SSF site in support of cell & gene therapy manufacturing activities.
• Act as client liaison for GMP hoteling and R&D CDMO operations.
• Evaluate/ manage the MFG Facilities process equipment, facilities, utilities, and HVAC equipment spare parts requirements to ensure required like-for-like spare parts are on hand.
• Ensure central utility plant, electrical/ UPS systems, HVAC Systems, and HEPA certifications are maintained per preventative maintenance program.
• Integrate Work Plans associated with each piece of equipment to ensure plans will be consistently executed and documented regardless of technician.
• Interacts with Suppliers/Consultants and/or vendors on Facilities and property matters.
• Review and approve Facilities GMP documentation including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols and summary reports, etc.
• Manage the direct relationship with landlords and/or property Managers, to ensure correct building maintenance and compliance with the agreements signed in the lease contract.
• Compliance with company policy for procurement of facilities services and goods.
• Compliance with local law and regulations (Building Taxes, Health and Safety).
• Lead and/or support Facility expansion projects and Tech Transfer activities for new projects.
• Participate in quality audits in support of GMP operations and regulatory requirements.
• Partner with Program Management, Manufacturing, Quality Control, Supply Chain and attend meetings in support of relevant manufacturing programs and activities.
• Must be available for on-call building emergencies 24/7/365.