Supervisor, Microbiology

Hikma Pharmaceuticals•Cherry Hill, NJ

About The Position

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Supervisor, Microbiology. In this role, you will be 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.

Requirements

Must have a BS and 7 years of pharmaceutical microbiology experience or a MS and 5 years of pharmaceutical microbiology experience. Must have 3-5 years of supervisory experience.
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, 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. Experience interacting with personnel from regulatory agencies

Nice To Haves

Pharmaceutical Microbiology experience with injectable/aseptic manufacturing preferred.

Responsibilities

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

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave