Associate Director, Engineering (Onsite)

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 Sterile Process Engineer at the Associate Director level will serve as a technical subject matter expert in process development, equipment and facility optimization, and new capabilities across the sterile development facility.  They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of a portfolio of sterile drug product formulations using the capabilities and facilities of the FLEx Center.  They will be responsible for the technical mentorship and coordination of work for process engineering colleagues to develop robust and innovative drug product manufacturing processes.  Close partnership with colleagues from Sterile Product Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure effective process development in support of clinical development.   

 

The successful candidate will drive continuous improvement to realize the vision of the FLEx Center as a learning facility.  They will serve as a role model for the 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 FLEx Sterile Process Engineering Lead in Pharmaceutical Operations & Clinical Supply. 

 

Primary Responsibilities:

·        Serve as a technical expert and mentor to a team of process engineers, tasked with becoming equipment and facility subject matter experts themselves.

·        Provide trouble shooting 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. 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

·        Execute investigations, as needed

·        Lead 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 minimum 4 years of relevant experience or B.S. or M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum 7 years of relevant experience.

Required Experience and Skills:

·        Knowledge of sterile 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

Preferred Experience and Skills:

·        Experience with GMP facility operations

·        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

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Required Skills:

Accountability, Accountability, Adaptability, Capability Development, Chemical Engineering, Clinical Development, Communication, Customer-Focused, Data-Driven Decision Maki