Associate Director, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

MSD

Remote Actively hiring
Rahway, New Jersey Posted 10 days ago $142,400–$224,100 / year
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At a glance

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TL;DR

The Associate Director of Process Engineering at the FLEx Center in Rahway, NJ leads non-sterile oral solids manufacturing with a focus on safety and quality for clinical supplies. This role involves strategic planning, mentoring a team of engineers, reviewing GMP documentation, and overseeing technical projects that enhance process understanding and scale-up efficiency. The ideal candidate will have extensive experience in small-molecule drug product processing, including robustness assessments and regulatory compliance, and must be adept at problem-solving and fostering collaboration within cross-functional teams. Key skills include knowledge of cGMP standards, FDA regulations, and hands-on optimization of manufacturing technologies such as spray drying and hot melt extrusion.

Skills

GMP cGMP FDA EMA Design of Experiments Quality by Design Change Control Root Cause Analysis Spray Drying Hot Melt Extrusion Batch Records Pharmaceutical Sciences Chemical Engineering Biomedical Engineering Clinical Trials Operations Process Optimization Process Robustness Assessments Technical Transfer Manufacturing Audits Drug Regulatory Requirements

What you'll do

  • Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality.
  • Mentor a team of process engineers through technical coaching and development guidance.
  • Review and approve GMP documentation including batch records, specifications, and change controls.
  • Provide technical oversight for continuous improvement efforts in operational and technical excellence.
  • Own complex technical projects using Design of Experiments and Quality by Design principles.

What we're looking for

  • Extensive experience in GMP manufacturing and process engineering for small molecule drug products.
  • Proven ability to lead and mentor a team of process engineers in a fast-paced environment.
  • Expertise in authoring, reviewing, and approving GMP documentation including batch records and change controls.
  • Strong knowledge of cGMP regulations and international regulatory requirements (FDA, EMA).
  • Experience with Design of Experiments (DoE) and Quality by Design (QbD) principles for process optimization.

Employer

About MSD

MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.

MSD currently has 14 open roles on FindRole.

Listed pay typically runs $117,000–$184,200 across 13 roles with salary data.

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