Director, Facilities and Engineering

Location
Emeryville, CA
Posted
Apr 20, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused on three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity, and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics (4DMT) is located in Emeryville, CA.

GENERAL SUMMARY:
This is a lead role for Facilities & Engineering in the operation of R&D and cGMP biopharmaceutical manufacturing facilities located in Emeryville, CA. The Director of Facilities & Engineering will take ownership of 4DMT buildings and processes supporting R&D and cGMP manufacturing. The Director will manage the functions of Facilities and Engineering and will have responsibility for planning, preventative, and corrective maintenance, installation of equipment, and building systems utilizing both internal and contract resources across multiple sites.  The position will also lead and maintain the EHS function for 4DMT, including environmental compliance needs for biopharmaceutical processing.  The role will be required to manage capital projects and equipment installations to support Corporate and GMP locations as directed. 
Responsibilities:
  • Facilities and Engineering Lead - 70%
  • Build and lead site engineering function and activities for current 4DMT R&D, QC, cGMP facilities, and Admin space planning and management
  • Lead the short- and long-term facility buildout strategy for 4DMT
  • Develop a site equipment management plan, including introduction and preventative maintenance of equipment
  • Manage and schedule shared external services and technical support. Responsible for vendor management, including contract negotiations
  • Help maintain facility cGMP status, including leading rapid response to facility air handling and HVAC challenges during production
  • Support planning and budging of Capital investments
  • Manage and enhance the in-house maintenance program, including metrology
  • Represent Facilities and Engineering in regulatory agency inspections
  • Act as primary 4DMT contact to landlord for facility management activities.
  • Select and implement appropriate CMMS application (e.g., Blue Mountain, Maximo, etc.) in close collaboration with IT
  • Aid and lead, when appropriate, facilities operations and ongoing expansion/construction
  • Play a significant role in equipment installation, operation, maintenance, and monitoring
  • Support facility qualification plans in close collaboration and partnership with Quality
  • Develop and implement facility preventive maintenance and calibration/metrology program
  • Manage all required certification and permitting, including periodic renewals
  • Team & Cross-functional Leadership - 30%
  • Coach, lead, and develop the Facilities and Engineering teams
  • Set and implement operations metrics (KPIs) to manage quality and cost
  • Establish function’s culture congruent with 4DMT’s Corporate culture
  • Design and deliver required site training
  • Assume responsibility for the site safety program, emergency response, and continuous improvement of site safety measures
  • Work in close collaboration with R&D, AD/PD, and cGMP manufacturing, ensuring facility readiness for research and production
  • Develop and implements policies and procedures for the Facilities and Engineering function
  • Other duties as assigned.’ Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Qualifications:
  • Bachelor’s degree in Engineering, Facilities Management, or other technical field preferred or relevant work experience
  • Experience:
  • 10+ years of biotech/pharmaceutical engineering experience with certification in facilities management a plus
  • 5+ years experience as facilities Director/Engineer with full responsibility for a facility
  • Proven track record leading and developing successful facilities and/or manufacturing teams
  • Ability to create annual and multi-year facilities operational plans and budgets in partnership with Finance
  • Demonstrated ability to follow established procedures and maintain documentation systems for cGMP and EHS compliance
  • Extensive knowledge of cGMP and ISO standards
  • Skills:
  • Effective interpersonal skills, project management, and organizational skills
  • Effective written and verbal communication
  • Experience with aseptic fill system
  • Experience with clean utility system
  • Experience with facility engineering design for cGMP operations
  • Physical Requirements
  • Adhere to 4DMT COVID protocols and policy 
  • Expectation to be onsite at 4DMT Emeryville location 50% of the time

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities