Associate Director, Engineering
Merck
5 months ago
On-site
Rahway, NJ
Operations
Responsibilities:
- Serve as technical mentor and process team member for the MACS Center (multi-modality drug substance development and GMP clinical manufacturing) at the Rahway, NJ facility.
- Build and lead a team of 5–10 engineers/operations specialists (and potentially insourced staff); own onboarding, technical growth, and people management (EDPs, compensation planning, performance reviews).
- Establish facility requirements to support operational readiness/qualification by the 2Q 2027 “ready for science” target.
- Contribute to equipment/facility design and system commissioning/qualification; enable facility startup and batch processing.
- Collaborate with development engineers/chemists, compliance representatives, Process R&D, Analytical, Quality, and Safety to ensure quality and safe delivery of clinical supplies; support compliance investigations/change management; author GMP documentation.
- As needed, support SSO and Prep Lab operations at the Rahway site.
Qualifications:
- Bachelor’s degree (ChemE, Chemistry, Biology, Pharmaceutical Sciences or related) + 8 years relevant experience; or Master’s + 7 years; or PhD + 5 years.
Required experience/skills:
- GMP clinical supply facility; equipment start-up/qualification; technical mentorship.
- Small molecule drug substance and/or biologics process development.
- Lead/support compliance investigations and change management; US/EU GMP and Safety compliance familiarity.
- PHA and/or LOPA; convert process needs into executable steps/procedures.
- Prepare SOPs and cGMP documents; quality systems; strong communication and organizational skills; independent problem-solving; build high-performance teams.
Desired:
- GMP facility design/start-up/commissioning; manage direct reports/matrix teams.
- Potent containment (e.g., isolators); process utilities (WFI, chillers, vacuum); automation systems (DeltaV/PLC); coordinate maintenance.
Benefits (explicit): annual bonus/long-term incentive (if applicable); medical/dental/vision, retirement (401k), paid holidays, vacation, compassionate and sick days.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting. Requisition ID: R390983.
- Serve as technical mentor and process team member for the MACS Center (multi-modality drug substance development and GMP clinical manufacturing) at the Rahway, NJ facility.
- Build and lead a team of 5–10 engineers/operations specialists (and potentially insourced staff); own onboarding, technical growth, and people management (EDPs, compensation planning, performance reviews).
- Establish facility requirements to support operational readiness/qualification by the 2Q 2027 “ready for science” target.
- Contribute to equipment/facility design and system commissioning/qualification; enable facility startup and batch processing.
- Collaborate with development engineers/chemists, compliance representatives, Process R&D, Analytical, Quality, and Safety to ensure quality and safe delivery of clinical supplies; support compliance investigations/change management; author GMP documentation.
- As needed, support SSO and Prep Lab operations at the Rahway site.
Qualifications:
- Bachelor’s degree (ChemE, Chemistry, Biology, Pharmaceutical Sciences or related) + 8 years relevant experience; or Master’s + 7 years; or PhD + 5 years.
Required experience/skills:
- GMP clinical supply facility; equipment start-up/qualification; technical mentorship.
- Small molecule drug substance and/or biologics process development.
- Lead/support compliance investigations and change management; US/EU GMP and Safety compliance familiarity.
- PHA and/or LOPA; convert process needs into executable steps/procedures.
- Prepare SOPs and cGMP documents; quality systems; strong communication and organizational skills; independent problem-solving; build high-performance teams.
Desired:
- GMP facility design/start-up/commissioning; manage direct reports/matrix teams.
- Potent containment (e.g., isolators); process utilities (WFI, chillers, vacuum); automation systems (DeltaV/PLC); coordinate maintenance.
Benefits (explicit): annual bonus/long-term incentive (if applicable); medical/dental/vision, retirement (401k), paid holidays, vacation, compassionate and sick days.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting. Requisition ID: R390983.