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 Specialist -Process Supervisor include the following:

The process supervisor role at the 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 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 assist on 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 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/IIa 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, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab or pilot plant/manufacturing facility

- OR-

• High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Required Experience and Skills:

• Mechanical aptitude and familiarity with chemical process development and process equipment.

• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.

• Experience operating/maintaining pilot scale or prep lab scale equipment.

• Effective communication skills and a collaborative mindset.

• Experience in conflict resolution and root cause analyses.

• Ability to build effective work relationships with a diverse workforce.

• Adaptable to a dynamic production environment.

• Relevant experience in a process development lab or pilot plant/manufacturing facility.

• As the building transitions towards operations must be able to rotate between 1st and 2nd shift on a weekly basis.

• Desire and willingness to learn, contribute and lead.

• Experience with coordinating maintenance activities around processing activities to support reliable facility operation.

Desired Experience and Skills:

• 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 investigations and change management.

• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)

• Experience with Potent Compound processing and containment systems (e.g., isolators).

• Experience interacting with process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.

• Experience working in an environment with an Automation System (DeltaV, PLC, etc.).

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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Job Posting End Date:

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Job Posting End Date:10/04/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R313835