Director, FLEx Non-Sterile Production

Job Description

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our company's drug product pipeline.  The FLEx Non-Sterile Production Lead will steer this facility within the FLEx network.  They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of formulations in support of oral and combination products using the talent, capabilities, and facilities of the FLEx Center.  They will be responsible for operating and maintaining a compliant, GMP-licensed manufacturing facility with the capability to manufacture supplies for early and late phase clinical trials.  Close partnership with supply chain colleagues from Quality, Regulatory Affairs, Facilities Management, Engineering, and Analytical will be required to ensure effective utilization of the facility in support of clinical development.   

The Production Lead is the steward of this key our company asset, ensuring its capabilities and operating model are developed and maintained over time to effectively support a dynamic and complex pipeline.  The Lead will sponsor and drive continuous improvement to realize the vision of the FLEx Center as a learning facility, founded on more inclusive collaboration in a workforce of great diversity, to enable the promise of the pipeline and more fully develop our talent.  They will help to create an entrepreneurial culture which values diversity in all its forms as a catalyst to innovation and product creation, recognizes the freedom to experiment and fail, is a safe environment to challenge, nurtures a strong sense of belonging, and motivates all to achieve their potential.  Critically, the Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have GMP facility operations experience, an affinity for hands-on problem solving, and excellent leadership and communication skills.

The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply. 

Primary Responsibilities:

• Oversee facility readiness including but not limited to equipment / facility cleaning and calibrations, materials availability, safety and environmental conditions to support development or GMP activities

• Manage, develop, and grow a team of facility-facing engineers and technicians

• Provide trouble shooting support on the shop floor

• Support internal capability development by evaluating new drug product technologies and deploying new technologies to develop pipeline assets

• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.

• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

• Participate in external and internal audits, tours, and inspections

• Ensure closure of investigations, as needed

• Establish and manage expense and capital expenditure financial budgets and forecasts associated with the FLEx Center

• Maintain facility and equipment systems in a state of permanent inspection readiness

• Recruit and develop staff, through objective setting, rewards and recognition, stretch leadership and/or technical assignments, and learning opportunities that broaden experience

• Sponsor and drive a culture of continuous improvement across this facility

Education Minimum Requirement: 

Ph.D. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years of relevant experience or B.S. or M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience

Required Experience and Skills:

• Knowledge of drug substance or drug product processing

• Experience with GMP manufacturing

• Effective interpersonal and communication skills, both verbal and written

• Excellent organizational skills to handle multiple priorities

• Track record of independent problem-solving

• Experience with leading complex teams / matrix management

Preferred Experience and Skills:

• Experience with GMP facility operations