Associate Director, Engineering

Merck & Co., Inc.

Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid
Raw material planning and procurement
Gmp release management experience
Sap validated system knowledge
This role serves as the single accountable lead for end-to-end management of raw materials and culture media supporting pilot-scale GMP manufacture of clinical biologics

Job Summary

  • This role serves as the single accountable lead for end-to-end management of raw materials and culture media supporting pilot-scale GMP manufacture of clinical biologics.
  • The position requires translating regulatory expectations into procedures while managing validated systems like SAP, RLIMS2, Veeva, and MEDS to ensure data integrity.
  • Candidates will drive continuous improvement initiatives to reduce lead times and costs while reporting material readiness risks to senior stakeholders.

Matching Summary

This role serves as the single accountable lead for end-to-end management of raw materials and culture media supporting pilot-scale GMP manufacture of clinical biologics.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • Raw material planning and procurement
  • GMP release management experience
  • SAP validated system knowledge
  • Supplier change notification management
  • cGMP and CFR regulatory compliance
  • Cross-functional project leadership

Nice-to-have

  • Lean Six Sigma certification
  • Biologics pilot-scale manufacturing
  • Single-use technology supply chain
  • Staff mentoring and supervision
  • Vendor qualification expertise

Key Requirements

  • BS, MS, or MBA in Engineering or Biological Sciences
  • Minimum 7 years relevant pharmaceutical industry experience
  • Proven experience with SAP and release documentation
  • Strong knowledge of cGMP, CFR, and data integrity
  • Project management and stakeholder management skills

Work Rights

Not specified

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