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Director, US Facilities

SUMMARY

This position is accountable for the integrated engineering, facility management and environmental health and safety operations for the Philadelphia facility.  Scope includes GMP and non-GMP requirements, execution of soft services to meet day-to-day operational needs, people management (staff, contractors and vendors), company culture championship, budget, large / small construction and renovation, and enterprise business continuity. 

This role will partner with corporate, clinical, CMC and research functions to achieve corporate-wide, clinical and manufacture objectives.   This is a highly visible hands-on role with an emphasis on strong people skills, staff mentoring, soft services and company culture.

 

RESPONSIBILITIES

  • Delivers and executes upon a vision to support daily operations.  
  • Provide oversight of the integrated GMP and non-GMP engineering, facility management and company EHS effort.  Develops strategies, operational budget planning, long range planning and support of facility capital projects.  Participates in internal audit/inspection.   Provides performance metrics.   Ensures GMP and non-GMP documentation / run books in place according to company policies and are in compliance with cGMP, state, and federal guidelines.
  • Provide leadership, coaching and mentoring for engineering, services and EHS staff. 
  • Accountable for developing, improving and executing strategies for soft site services including but not limited to office space layout and move planning, supply ordering and distribution, company and general meeting / conferencing support, operational documentation (run book), policy and procedure, site security, office maintenance and cleaning, landlord relations, site emergency, and general office oversight.  Ensure that all facility utilities are 100% operational, safe and well-maintained.  Hands on in soft services execution.
  • Own integrated enterprise business continuity efforts for US site(s).

 

REQUIREMENTS

  • Bachelor’s degree in an engineering discipline, architecture or related field or equivalent experience, advanced degree preferred with 15+ years of facilities and maintenance operations experience in the biotechnology or pharmaceutical industry.
  • 15 – 20 years experience with proven track record of successful facilities management leadership experience as demonstrated by articulated results and accomplishments.
  • Good project and operations management skills.
  • Mix of engineering, soft services and EHS experience.
  • Self-starter capable of operating strategically and tactically to achieve goals
  • Experience in building construction during live GMP manufacturing operations.
  • Demonstrated experience in a sterile/aseptic injectable Pharmaceutical manufacturing.
  • Strong knowledge in mechanical, electrical, plumbing, HVAC, and, safety systems in GMP environment.
  • Exceptional customer service, relationship building and communication skills.
  • Strong leadership skills with a focus on staff development and team building.
  • Strong interpersonal, verbal and written communication skills are essential.
  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
  • Experience with systems investigation and root cause analysis tools.
  • Experience with CMMS, and BMS program design and implementation.
  • Skilled at creating and delivering presentations.
  • Experience in pharmaceutical and/or biopharmaceutical industry facility ramp up and equipment layout, installation and calibration
  • Self-motivated with a strong sense of ownership in areas of responsibility.
  • Able and willing to take on a role of culture champion to help grow site culture.
  • Ability to adapt in a constantly evolving environment.
  • Able to build and lead team.
  • Experience in safety programs, emergency response, biosafety, LOTO, confined space, people safety, environmental hazard, and related implementation / execution of ISO standards.
  • Ability to write department operational/maintenance and engineering SOP’s.
  • Able to grow integrated function to next level aligned to company growth plans.
  • Familiar with OSHA, EPA, PA DEP.
  • Familiar with construction, mechanical, electrical and plumbing practices.
  • Good computer skills with high proficiency in Microsoft Office Word, Excel, Powerpoint and MS Project. AutoCAD skills would be beneficial.
  • Familiar with RFQs/RFPs and contracting practices.
  • Strong communication skills - ability to communicate effectively, showing consideration and concern, with ALL levels of the organization ranging from “Operator” to “CEO”
  • Must be able to manage competing priorities (i.e. ability to organize and prioritize work to meet deadlines).
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