TAI is actively seeking a Director of Facilities for a pharmaceutical client located in Philadelphia, PA. This person will be responsible for overseeing the Facilities and Engineering functions at the client site by providing consistent, reliable, and high-quality services in support of GMP and non-GMP operations. Scope includes developing, implementing and the continual improvement of building and equipment strategies in compliance with GMP. Additionally, this role is responsible for executing soft services to meet day-to-day operational needs, people management (staff, contractors, and vendors), company culture championship, budget, and large / small construction and renovation projects. This role will partner with corporate, clinical, CMC and research functions to achieve corporate-wide, clinical and manufacture objectives.

Key Responsibilities:

• Develops strategies, operational budget planning, long range planning and support of facility capital projects. Oversees construction/renovation and smaller projects in accordance with established timelines and budget, while ensuring minimal disruption to ongoing CMC operations
• Provide oversight of the integrated engineering and facility management by delivering and executing upon a vision to support daily GMP and non-GMP operations.
• Ensure Facilities and Engineering activities are performed in compliance with GMP requirements through the development, implementation, and strong oversight of applicable GMP strategies. Participate in interdepartmental teams to resolve building and equipment compliance issues/improvements. Participate as requested by asset owner in process equipment selection. Develop/revise/implement GMP policies and procedures. Participate and ensure compliance with Quality Systems (change control, deviations, internal audits/inspections).
• Provide leadership, coaching and mentoring for Engineering and Facility 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.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in an engineering discipline, architecture or related field or equivalent experience, advanced degree preferred with 15 years of GMP facilities and maintenance operations experience in the biotechnology or pharmaceutical industry.
• 10 years’ experience with proven track record of successful GMP facilities management leadership experience as demonstrated by articulated results and accomplishments.
• Good project and operations management skills.
• Mix of engineering and soft services.
• Self-starter capable of operating strategically and tactically to achieve goals
• Experience in building construction during live GMP manufacturing operations.

Desirable:

• Demonstrated experience in a sterile/aseptic injectable Pharmaceutical manufacturing.

Skills:

• 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.
• Experience in EHS and corporate business continuity efforts.
• Skilled at creating and delivering presentations.
• Experience in pharmaceutical and/or biopharmaceutical industry facility ramp up and equipment layout, installation, calibration and maintenance
• 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.

Desired:

• Familiar with Pa-OSHA, Pa-EPA, Pa County building and safety codes and regulations.
• 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).
• Experience with Biologics License Application (BLA) requirements / needs