Director, Facilities & EHS

Job Summary

Responsible for overall facility management including EHS at Transpire Bio. Maintain overall plan and strategy for ensuring the facility is built and maintained in a cGMP status at all times complying with all appropriate regulations and standards.

Essential Functions

• Develops and enforces policies and procedures related to facilities, health, safety and environmental issues in the workplace by conducting risk assessments to identify workplace hazards and developing appropriate procedures to remediate the risks.
• Trains staff in new safety procedures and best practices and work with other departments to ensure that all company guidelines are followed.
• Coordinates with HR and Legal with insurance carriers to ensure that appropriate coverage is in place to cover any potential risks.
• Provides oversight of facilities, environmental health and safety compliance in the workplace with federal, state and local regulations, including fire safety and OSHA regulations.
• Plans, budgets, and schedules facilities modifications including cost estimates, bid sheet, layouts, and contracts for construction and acquisitions.
• Creates and monitors the facility budget.
• Schedules and manages routine facility and utilities maintenance and oversee all contractors working in the facility.
• Manages facility maintenance and calibration personnel, and oversees the entering of PM information into the Calibration Manager Software Program
• Manages facility cleaning contractors and waste disposal.
• Assists with long-range planning and renovations/additions to support future facility needs or expansion into additional facilities.
• Manages facility maintenance and calibration personnel
• Additional Responsibilities
• Initial activities will include developing Standard Operating Procedures for the start up, shut down, usage and preventative maintenance for all systems and equipment.
• Maintain drawings as directed by the Change Control Program
• Develop a facility start up plan that includes daily plant checks, equipment/systems spare parts, and Operating Manuals
• Develops and manages waste and materials recycling programs
• Serves as primary contact for environmental regulatory agencies including audits, inspection, reports and general communications investigates environmental incidents and prepares incident reports
• Good technical writing skills.
• Excellent communication, problem-solving, planning and organization skills.
• Ability to work independently, including making sound decisions and managing priorities that are in alignment with site and company directives.
• Ability to mentor and direct junior team members.
• Ability to work within a team-oriented environment.
• Ability to work off hours and weekends.

Education

Bachelor’s Degree or equivalent

Work Experience

• 7 - 10 years of experience in cGMP facilities or property management in a pharmaceutical environment. Experience in inhalation drug products is a plus.
• Strong interpersonal skills.
• Excellent communication skills.
• Good knowledge of regulations and laws including FDA GMP requirements for facilities.
• Multitasking abilities.
• Good problem-solving skills.
• Good negotiation skills.
• Experienced with Microsoft Office suite and email systems
• Prefer: New facility start-up experience.