Associate Director , Microbiology

Glenmark Pharmaceuticals • Monroe, NC

396d

About The Position

The Associate Director of Microbiology at Glenmark Pharmaceuticals is responsible for managing a team of microbiologists and overseeing all microbiological quality aspects of pharmaceutical manufacturing, including sterility, environmental monitoring, and contamination control strategies. This role involves implementing procedures, leading validation programs, and ensuring compliance with regulatory standards while maintaining quality systems and managing budgets effectively.

Requirements

• Bachelor's degree in Microbiology or related field.
• 10-15 years of experience in the pharmaceutical industry, particularly in formulation facilities.
• Experience in injectable facilities is an advantage.
• Knowledge of cGMP, validations, regulatory guidelines, and US Pharmacopoeias.
• Experience with internal auditing and handling regulatory inspections.

Nice To Haves

• Experience dealing with multiple audits personally.

Responsibilities

• Manage a team of microbiologists overseeing microbiological quality aspects of pharmaceutical manufacturing.
• Implement Entry/Exit and gowning procedures for classified areas.
• Conduct disinfection validation studies for various disinfectants.
• Lead media fill programs, cleaning verification programs, and sterilizer validation programs.
• Prepare and implement Standard Operating Procedures (SOPs) and Standard Testing Procedures for microbiological testing.
• Oversee validation and verification of microbiological test methods.
• Act as a Subject Matter Expert (SME) for microbiological aspects during audits.
• Prepare financial budgets and ensure compliance with resource allocation.
• Maintain quality system controls to prevent critical and major market complaints.
• Ensure compliance with statutory and regulatory requirements.
• Reduce wastages and improve efficiency in the analysis process.
• Prepare the microbiology laboratory for internal and external audits.
• Ensure online documentation and compliance with Good Microbiology Laboratory practices.
• Update specifications and standard test procedures for the microbiology section.
• Distribute work among subordinates in the microbiology section.
• Procure consumables and ensure maintenance of laboratory instruments.
• Prepare risk assessments for microbiology processes.
• Ensure timely sampling, analysis, and release of environmental and water samples.
• Ensure training of subordinates in microbiology department as per job requirements.
• Review change controls, incidents, and deviations related to microbiology.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree