Pharma Manufacturing Operations Leader

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance

Paid time off

Paid holidays

401(k)

Volunteer time off

Job summary

Grand River Aseptic Manufacturing Inc. (GRAM) is seeking a senior leader to manage Drug Product Manufacturing Operations, including sterile filling and aseptic processing. You will own processes and equipment at the Butterworth facility and support expansion to Patterson North, driving throughput and regulatory compliance.

You will lead a team, ensure CAPAs are effective, and partner with Quality to meet capacity, quality, and customer service targets in a fast-paced, science-driven environment.

Qualifications

• Bachelor's degree in Life Sciences/Engineering or related field; equivalent work experience considered.
• Minimum 5 years of leadership in a cGMP pharmaceutical/regulated manufacturing environment.
• Experience with regulated drug manufacturing, cGMP, FDA guidelines, and multinational standards.
• Proficient in Word, Excel, and Outlook.

Responsibilities

• Manage Drug Product Manufacturing Operations including Preparation, Formulation, Filtration, and Sterile Filling.
• Serve as Process Owner for Butterworth Facility processes and equipment, including cleanroom control.
• Oversee daily/weekly/long-term manufacturing activities to meet capacity, quality, and customer service.
• Train and provide leadership oversight during expansion to Patterson North facility.
• Ensure scheduling and resource planning to meet production plans.
• Drive improvements, CAPAs, and adherence to regulatory requirements.
• Lead cross-functional teams and participate in technology transfer and process changes.

Skills

Leadership

cGMP expertise

FDA guidelines

Six Sigma/Lean

CAPA/Deviations

Regulatory documents

People development

Data analysis

Cross-functional collaboration

Shop floor leadership

Education

Bachelor's degree in Life Sciences/Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Grand River Aseptic Manufacturing Inc. (GRAM) is seeking a senior leader to manage Drug Product Manufacturing Operations, including sterile filling and aseptic processing. You will own processes and equipment at the Butterworth facility and support expansion to Patterson North, driving throughput and regulatory compliance.

You will lead a team, ensure CAPAs are effective, and partner with Quality to meet capacity, quality, and customer service targets in a fast-paced, science-driven environment.