Associate Director – Process/Facility Engineering

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 Director – 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 include the following:

The process/facility engineer role at the Associate Director level will serve as a technical mentor and 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. The Associate Director 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 lead and mentor 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 the MACS facility the Associate Director may need to provide direct support of the 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, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 10 years relevant experience, or a Master’s degree with 9 years of relevant experience, or a PhD degree with 6 years of relevant experience.

Required Experience and Skills:

• Experience in GMP clinical supply facility.

• Experience with Equipment start-up and/or qualification.

• Experience providing technical mentorship.

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

• Experience in leading or supporting compliance investigations and change management.

• Familiarity with US and EU GMP and Safety compliance regulations

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

• Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.

• Experience with quality systems

• Effective interpersonal and communication skills, both verba