Associate Director, Engineering

Job Description

Description

The Modality Agnostic Chemistry Scaleup (MACS) Operations 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 MACS Operations Lead Senior Director as a member of the MACS Operations Team at the Rahway NJ facility.

The Associate Director will serve as a technical mentor and process team member supporting the MACS Center, which 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 incumbent will build and lead a team of 5-10 engineers and operations specialists, and potentially insourced staff as well. The Associate Director will be responsible for their team’s onboarding and technical growth, as well as people management responsibilities such as employee development plans (EDP), compensation planning, and performance reviews. Since the facility is embarking on operational readiness and qualification the Associate Director will work alongside their peers in the MACS Operations Team, the Enabling Facilities group and other operations areas such as the SSO and Prep Lab (see below), as well as key stakeholders in Process R&D, Analytical, Quality, and Safety. They will be instrumental establishing the requirements in this first-of-a-kind facility by the ready for science target date of 2Q 2027. 

As the MACS 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 and subsequent batch processing. The selected candidate is expected to build and develop 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 at the Rahway site 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 8 years relevant experience, or a Master’s degree with 7 years of relevant experience, or a PhD degree with 5 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 and 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 t