Process Supervisor, Senior Specialist

Job Description

Description 

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure.  Responsibilities of the Senior Specialist –Process Supervisor include the following: 

The process supervisor role at the Senior Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Senior Specialist will serve as a team member of the MACS Center Detail Design Phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.   

As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected candidate is expected to be a key part of an operations team and foster a culture of collaboration, learning and innovation.  

As MACS becomes operational the MACS Process Supervisor will supervise and participate in daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements to meet MACS objectives and customer requirements.  The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.  This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the building performance.  Ultimately, this position is expected to work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building.  This role will also be responsible for the prioritization and assignment of daily activities for the operations staff.  

Additional Supported Areas 

As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas such as:  

Small Scale Organics Pilot Plant (SSO):  The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization.  The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportun