Manufacturing Manager: Lead cGMP Ops & Process Excellence

Grand River Aseptic Manufacturing, Inc.

Grand Rapids (MI)

On-site

USD 110,000 - 140,000

Full time

3 days ago
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Benefits offered by this job

Benefits from day 1
Volunteer time off
PTO 104 hours
Wellness time off
Paid holidays
401(k) vesting

Job summary

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI is seeking a Manufacturing Manager to direct Drug Product Manufacturing Operations, including preparation, formulation, filtration, and sterile filling, with responsibility as Process Owner for Butterworth and support for Patterson North facility onboarding.

The role requires a life sciences/engineering degree, 5+ years of leadership in cGMP settings, and strong regulatory knowledge.

Qualifications

  • Bachelor’s degree required or equivalent work experience.
  • Minimum 5 years of leadership in a cGMP pharmaceutical environment.
  • Experience with FDA guidelines and multinational regulatory standards.
  • Proficient in Microsoft Word, Excel, and Outlook.

Responsibilities

  • Ensure activities meet QA and client standards.
  • Collaborate with Quality to troubleshoot processes and implement CAPAs.
  • Review and approve CAPAs and non-conformance reports.
  • Lead continuous improvement and drive throughput.
  • Manage resources to meet annual demand and monthly production plans.
  • Oversee weekly scheduling of prep, formulation, and filling.

Skills

Leadership
cGMP knowledge
Regulatory compliance
Problem solving

Education

Bachelor’s degree in Life Sciences/Engineering or related field

Tools

Microsoft Word/Excel/Outlook

Job description

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI is seeking a Manufacturing Manager to direct Drug Product Manufacturing Operations, including preparation, formulation, filtration, and sterile filling, with responsibility as Process Owner for Butterworth and support for Patterson North facility onboarding.

The role requires a life sciences/engineering degree, 5+ years of leadership in cGMP settings, and strong regulatory knowledge.

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