Director of Sterile Manufacturing & Operations

Glenmarkpharma; Monroe (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Glenmark is seeking a Director of Operations in Monroe, NC to oversee sterile injectable manufacturing, filling, and packaging. The role emphasizes optimizing productivity, reducing downtime, and ensuring adherence to safety standards across multiple shifts.

Responsibilities include equipment qualification, process setup, site transfers, media fills, aseptic environments, and regulatory readiness. Strong leadership and cross-department collaboration are essential for success.

Qualifications

• Bachelor's degree in a relevant scientific field is required; Master's preferred.
• 18+ years in pharmaceutical manufacturing; sterile/aseptic experience required.
• Experience with USFDA-regulated facilities and aseptic filling technologies.

Responsibilities

• Lead plant-wide OEE initiatives and continuous improvement across manufacturing areas.
• Manage budget compliance and manufacturing costs within established budget.
• Coordinate with Procurement, QA, Regulatory, and R&D to run operations effectively.
• Ensure timely batch records closure and CGMP compliance.
• Develop team through training and talent management programs.

Skills

Sterile manufacturing

Aseptic processing

CGMP compliance

Process improvement

Budget management

Stakeholder collaboration

Regulatory audits

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Microbiology

Bachelor's degree in Engineering

Master's degree preferred

Job description

Glenmark is seeking a Director of Operations in Monroe, NC to oversee sterile injectable manufacturing, filling, and packaging. The role emphasizes optimizing productivity, reducing downtime, and ensuring adherence to safety standards across multiple shifts.

Responsibilities include equipment qualification, process setup, site transfers, media fills, aseptic environments, and regulatory readiness. Strong leadership and cross-department collaboration are essential for success.