Director, FLEx Process Engineering

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Job Description

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company’s drug product pipeline.

The FLEx Process Engineering Lead drives process development expertise, equipment and facility optimization, and new capabilities across all non-sterile development facilities.

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 developing equipment and process subject matter experts who will partner with formulators and device engineers to develop robust and innovative drug product manufacturing processes.

Close partnership with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure effective process development in support of clinical development.

The Process Engineering Lead stands at the vanguard of commercial process development, ensuring that FLEx capabilities, talent, and its 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 extensive drug product process development 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 :

• Manage, develop, and grow a team of process engineers, tasked with becoming equipment and facility subject matter experts
• Provide troubleshooting support on the shop floor
• Drive 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
• Support maintenance of 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
• Experience with leading organizational change
• Experience in leading and supporting quality investigations and change management
• Experience with quality systems
• Familiarity with US and EU GMP and Safety compliance regulations
• Experience with SAP, ERP or MES systems
• Familiarity with computer systems and applications including but not limited to : Programmable Logic Controllers (PLCs), Calibration / Maintenance Database Systems

Employee Status : Regular

Relocation : Domestic

VISA Sponsorship : Yes

Travel Requirements : 10%

Shift : 1st - Day

Job Posting End Date : 09 / 23 / 2024

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