Manager, Microbiology

JOB PURPOSE

This position is responsible for the supervision of microbiologists performing pharmaceutical microbiological procedures and the accuracy of test results and raw data generated. The qualified candidate must possess a strong background in sterility testing using isolator technology, sterility testing validation, Biological Indicator studies, water system sampling and testing, bioburden testing, Bacterial Endotoxin Testing (BET), bioburden and BET validation testing, microbial identifications, disinfectant studies, Antimicrobial Effectiveness Testing (AET) and AET validation, growth promotion testing of media/diluents, preparation of cryopreserved microbial cultures, and media/diluent preparation. The qualified candidate must have experience interacting with the FDA and other regulatory/audit groups. This position will be responsible for resolving technical/equipment problems, implementing corrective/preventive actions, writing/ revising standard operating procedures, forms, protocols, test methods and change controls, and providing guidance to less senior staff.

KEY ACCOUNTABLITIES

Regular and predictable onsite attendance and punctuality.

Control the workflow of the microbiology laboratory by supervising, planning, organizing, and directing the activities of the group to support production, stability program, technical services, and R&D. Ensure adequate supplies and equipment are available for testing and maintain expenses at or below budget. Analyze workflow, prepare metrics, and make recommendations to improve productivity and efficiency of group and generate cost savings.

Enforce policies and procedures by monitoring the testing techniques and accuracy of all records and documentation that is done in the lab to ensure compliance. Ensure that team members are properly trained and proficient before allowing them to perform any tasks. Review laboratory records for accuracy,completeness, compliance, and conformance to specifications. Approve laboratory records and ensure initiation of laboratory events and investigations as required. Ensure compliance in the group and keep the department ready for both internal and external audits.

Oversee instrument/equipment maintenance and calibration programs. Troubleshoot and resolve instrument/equipment problems. Ensure maintenance and calibrations are done in accordance with required schedule. Develop proposals for new laboratory systems and equipment. Execute validation studies, prepare summary reports, and change controls. Stay current on laboratory instruments and methods. Ensure completion of all protocols, validations, and summary reports in a timely manner.

Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current on regulations and industry best practices pertaining to the group and update SOPs to improve compliance. Prepare and execute change controls as needed to support changes to the program.

Make appropriate staffing recommendations, support laboratory cross-training efforts, evaluate team member performance, perform appraisals, and ensure team members have development plans.

Resolve deviations. Investigate and/or work closely with investigators to determine root cause of deviations. Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.Interact with FDA and other regulatory/audit groups. Working knowledge of FDA regulations and application of GLPs and GMPs QUALIFICATIONS

BS and 8 years of pharmaceutical micorbiology experience or a MS and 6 years of pharmaceutical micorbiology experience. EXPERIENCE

Pharmaceutical Microbiology experience with parenteral/aseptic manufacturing

3 - 5 years of supervisory experience SKILLS

Excellent organizational and project management skills and ability to handle multiple projects

Excellent writing and computer skills and ability to present data in a logical manner

Excellent interpersonal, communication, influencing, leadership, and negotiation skills

Understanding of scientific strategies and ability to invent new methods or new avenues of investigation

Demonstrated effectiveness in task completion, decision making, and problem solving

Working knowledge of FDA regulations, application of GLPs and GMPs What We Offer

Clean climate-controlled working environment

Annual performance bonus potential

Paid time off

Company holidays

Safety and Quality is a top organizational priority

Career advancement/growth opportunities

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms

Location: