Associate Specialist, Operations; Onsite

Job Description Associate Specialist – MACS Operations Specialist (P1)

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 MACS Operations Specialist position will report to the Associate Director, Engineering 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 Operations Specialist include the following:

The Operations Specialist role at the Associate 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 under construction in Rahway, New Jersey. They will serve as a team member for the MACS Center construction and startup 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, equipment or material testing, system commissioning/qualification, as well as other critical activity work streams to enable facility startup. Additionally, the selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training necessary to operate and maintain a new business area after completion of the facility startup.

The selected candidate is expected to be a key part of the operations team and foster a culture of collaboration, learning and innovation.

They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center is operational, additional tasks could include equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development.

This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during “wet chemistry” operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (e.g., dry milling).

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

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 opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.

The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. The Prep Lab includes a cleanroom suite for GMP small-scale manufacturing of potent and multi-modality…