About this role
Associate Director - Process/Facility Engineering within the Modality Agnostic Chemistry Scaleup (MACS) Operations team. The role leads engineering and operations readiness for a new GMP clinical manufacturing plant in Rahway, NJ, including commissioning/qualification, documentation, and compliance support.
Key Responsibilities
- Lead and mentor a team of 5-10 engineers and operations specialists including onboarding, EDPs, compensation planning, and performance reviews
- Contribute to equipment and facility design and drive system commissioning/qualification for operational readiness
- Support facility startup and subsequent batch processing activities
- Collaborate across Process R&D, Analytical, Quality, Safety, and compliance representatives to ensure quality and safe clinical supplies
- Author GMP documentation and support compliance investigations and change management
Technical Overview
Responsible for engineering execution across equipment and facility design inputs, system commissioning and qualification, and enabling batch processing for a new potent, multi-modality drug substance facility. Supports compliance investigations, change management, and authoring GMP documentation to ensure safe, high-quality clinical supply delivery.
Ideal Candidate
The ideal candidate is an engineering/process-facility leader who can build and manage a team of 5-10 engineers and drive operational readiness for a new GMP clinical manufacturing facility. They have hands-on experience with equipment and facility design inputs, system commissioning/qualification, batch processing startup, and supporting compliance investigations and change management.
Must-Have Skills
process/facility engineeringcommissioning/qualificationequipment and facility design contributionbuild and lead a team of 5-10 engineers and operations specialistspeople management responsibilities including employee development plans (EDP)compensation planningand performance reviewsauthor GMP documentationsupport compliance investigations/change managementensure quality and safe delivery of clinical supplies
Nice-to-Have Skills
support facility startup and subsequent batch processingsupport of enabling facilities including Small Scale Organics Pilot Plant (SSO)support of SSO and Prep Lab activities
Required Skills
process/facility engineeringpeople managementemployee development plans (EDP)compensation planningperformance reviewsequipment and facility designsystem commissioningqualificationGMP clinical manufacturingbatch processingprocess developmentcompliance investigationschange managementauthor GMP documentationQualitySafetymulti-modality drug substance development (small moleculemacrocyclic peptidesbioconjugates)
Hard Skills
process/facility engineeringprocess team onboardingpeople managementemployee development plans (EDP)compensation planningperformance reviewsequipment designfacility designsystem commissioningqualificationGMP clinical manufacturingbatch processingprocess development supportcompliance investigationschange managementauthor GMP documentationfacility operations supportpotentmulti-modality drug substance developmentsmall moleculemacrocyclic peptidesbioconjugatescollaboration with development engineers and chemistscollaboration with Quality and Safety
Soft Skills
technical mentorshipteam leadershipcollaborationcommunicationcross-functional partnershipfostering a culture of learning and innovation
Keywords for Your Resume
Associate Director - Process/Facility EngineeringAssociate DirectorEngineeringModality Agnostic Chemistry Scaleup (MACS)MACS Operations groupChemical Engineering Research & Development (CERD)MACS Operations TeamRahway NJGMPGood Manufacturing Practice (GMP)process/facility engineeringequipment and facility designsystem commissioningqualificationoperational readiness and qualificationready for science target date2Q 2027batch processingprocess developmentcompliance investigationschange managementauthor GMP documentationpeople managementemployee development plans (EDP)compensation planningperformance reviewssmall moleculemacrocyclic peptidesbioconjugatesenabling facilitiesSmall Scale Organics Pilot Plant (SSO)SSOPrep LabQualitySafetyProcess/Facility Engineering
Deal Breakers
Must demonstrate process/facility engineering experience including commissioning/qualification or equivalent, Must demonstrate ability to lead people management (5-10 engineers/operations specialists) including performance reviews and employee development plans (EDP), Must demonstrate GMP documentation authoring experience, Must demonstrate experience supporting compliance investigations and/or change management
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