Company

Facilities Associate Director/Director

Burlington, MA, USA

Company Overview: ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.

Site Description: ProtaGene has recently moved into a 20,000-sf. laboratory and office space in Burlington, MA. The site maintains advanced instrumentation for characterization of biologic and gene therapy drug products, including specialized space for clinically regulated genomics work, as well as general lab support facilities such as cold/freezer storage, cryogenic storage, glass washing and sterilization equipment, liquid nitrogen storage, IT server equipment, central gas and utility spaces, etc.

Candidate Role: We are seeking a highly motivated Facilities Associate Director/Director for the US Site in Burlington, MA to lead the facilities function in a fast-paced, high growth CRO environment. This is a unique opportunity to join a quickly growing, dynamic team in a brand-new state of the art facility and build the Facilities function.  Reporting to the US Site Head this individual will be a key business partner and have full responsibility for the building management with landlord, offices, laboratories, space expansion and vendor management.

Key Responsibilities

Facilities Management and Capital Projects:

  • Develop and execute against strategic facilities plan, proactively addressing current building and space systems and subsystems, and operational changes for ProtaGene’s Burlington MA site; collaboration with all relevant leaders/team members to effectively support scientific and technical operations
  • Assist with lab process and related system support
  • Implement all necessary preventative maintenance programs including the site asset management system
  • Interface with landlord’s asset management team
  • Partner with the Laboratory Operations / Laboratory Services team in growing laboratory support services, ensuring high quality and reliable support for ProtaGene Scientist teams. This includes planning and executing capital and expense investments, procurement in laboratory infrastructure, laboratory equipment, equipment maintenance and calibration contracts
  • Participate in company risk prioritization and management processes, develop, and implement business continuity planning for laboratory and office in collaboration with the Leadership Team

 

Lab and Office Operations:

  • Manage comprehensive Environmental, Health & Safety programs and processes. Collaborate with the Safety Committee to understand current needs and support adaptations to meet evolving needs, including hazardous materials management
  • Develop positive working relationships and act as point-of-contact for 3rd-party facility/lab management team (maintenance technicians, shipping & receiving, etc.)
  • Lead the day-to-day Site Operations (Workplace, Laboratory and Facilities functions), CAPEX and OPEX budgeting, resource prioritization, develop scope of projects, user requirements, specifications, create requests for proposals (RFP’s), evaluate statement of work and cost proposals, contracts, project management requirements
  • Coordinate the development, implementation, and preservation of key standard operating procedures and policies related to facilities, and as appropriate for operations performed cross-functionally. This includes preventative, condition-based and on-demand maintenance programs
  • Maintain all relevant documentation related to the facility and ensure suitable change management system are implemented
  • Develop and maintain, a comprehensive facilities help-desk system, to ensure facilities issues are being tracked and proactively addressed
  • Participate in company risk prioritization and management processes, develop, and implement business continuity planning for the laboratory and office
  • Maintain local and state government documentation requirements relating to facilities and operations, ensure compliance with all applicable health and safety laws and regulations, Maintain all pertinent permitting for the Burlington site
  • Support the development of facilities management strategies, including conference room support, space management, visitor management and, physical security
  • Provide oversight for shipping and receiving support

 

Procurement and Vendor Management:

  • Create Requests for Proposals (RFPs) for full complement of vendors to support the lab and office environment, including equipment purchase
  • Develop maintenance contracts with service providers specifically for scientific equipment
  • Work with providers to develop a robust approach to consumables management (Just in Time, Point of Use, compressed gases, liquid nitrogen, etc.)
  • Ensure equipment preventative maintenance/calibration programs is fully operational

Qualifications

  • Bachelor’s degree in sciences, engineering, or business administration or a combination of equivalent experience and relevant professional development and or industry certifications
  • Experience in Biotech/Pharma with a minimum of 10+ years of experience with a technical background preferred (mechanical and or electrical engineering, mechanical engineering technology, or scientific operations)
  • Deep understanding of the research & development environment, as well as a fundamental understanding of clinical regulatory processes to support operation of a Quality environment
  • Experience with the procurement and negotiation of goods and services in a lab environment
  • Demonstrated knowledge of regulations concerning biohazard facilities, and biological and chemical material handling, familiarity with the Burlington Biosafety Committee and its workings
  • Experience with maintenance of automation equipment
  • Exceptional time management skills and ability to manage multiple projects simultaneously
  • Clear written communication and sound judgment
  • Interpersonal, relationship-building, networking skills and customer service approach
  • Collaborative approach with colleagues and partners; ability to influence without authority is important
  • Resourcefulness; strong organizational, planning, and problem-solving skills
  • Ability to prioritize work, organize and handle multiple projects simultaneously, and interface with colleagues, internal and external clients, and staff at all levels
  • Project management skills and deep understanding of Project Management tools/resources in the delivery of the Facilities Management function as well as potential capital projects
  • Research skills and the ability to draw information from various sources, including people
  • MS Office suite a must, ability to use MS Project also important
  • Previous management experience a plus (This position will be an individual contributor role; however, it may grow to have direct reports over time)

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