Associate Specialist – MACS Process/Facility Engineer

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 a high degree of technical and project management responsibility. The Associate Specialist – Process/Facility Engineering position will report to the 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 Associate Specialist – Process/Facility Engineer include the following:

The process engineer role at the Associate Specialist level will serve as a process 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. They will serve as a team member of the MACS Center Basis of 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 a team of process/facility engineers 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, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company’s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities.

Additional Supported Areas

As required and in addition to support of current capital projects the Associate 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 opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.

Prep Lab Area:  The Prep Lab is used to generate data which contributes to process definition and provides Phase I/II clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale.  Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.

Education Minimum Requirement: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field.

Required Experience and Skills:

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn, contribute and lead.

• Track-record of independent problem-solving.

• Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.

• A strong mechanical aptitude.

• Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.

Desired Experience and Skills:

• Experience working in a GMP clinical or manufacturing supply facility.

• Experience with GMP facility design, equipment start-up and/or qualification.

• Experience with small molecule drug substance and/or biologics process development.

• Experience in supporting compliance inv