Lead Laboratory Microbiologist

4 days ago

Mahwah, New Jersey, United States Joulé Full time
Job Title: Lead Laboratory Microbiologist

About the Role:
The Lead Laboratory Microbiologist will be responsible for planning, organizing, and directing the laboratory to effectively utilize employees and equipment to meet and exceed cGMP requirements and established Key Performance Indicators (KPls). The successful candidate will provide direct on-site analysis of day-to-day operations, including workflow adjustments, test performance, and quality compliance.

Key Responsibilities:
• Devising sound hiring strategies based on business needs and maintaining adequate staffing by interviewing, hiring, training, and performing competency assessments of personnel.
• Performing scheduling, planning, staffing, and monitoring of workflows based on business needs.
• Providing staff development through feedback aimed towards performance development and review.
• Performing corrective counseling when necessary.
• Procuring appropriate supplies and equipment to maximize department efficiency while adhering to established budgetary and quality goals.
• Leading equipment life cycle management and asset/investment optimization processes, evaluating and purchasing equipment based on S&OP demand within the allocated budget.
• Assuring the qualification of laboratory equipment and validation of microbial methods, approving protocols and respective reports.
• Overseeing or initiating in-sourcing of microbial methods to attract clients and generate revenue.
• Working with the Business Development group for initiation of Work Orders for any out-of-scope work done for clients.
• Providing technical oversight of areas of responsibility and serving as a technical resource for problem-solving and process improvement to ensure accurate test performance.
• Forming project teams and championing the execution of agreed projects using project management, problem-solving, and operational excellence tools.
• Investigating and documenting non-conforming events and environmental excursions, serving as an approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records.
• Monitoring effectiveness of quality systems, change control activities, and their completion, for both internal, client, and regulatory agency audit findings.
• Troubleshooting and recommending process improvements to achieve greater efficiency and meet quality goals.
• Leading a strategy to simplify and standardize equipment software architecture, enabling digital integration.
• Ensuring alignment and efficient continuity in laboratory practices between sites.
• Identifying and executing Continuous Improvement Projects for the department, leading and developing best practices in the laboratory.
• Leading/participating in department and cross-functional meetings.
• Supporting, implementing, and ensuring compliance amongst all departments, company policies, and procedures.
• Ensuring compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Interacting with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols to accurately reflect current practices.
• Performing microbiological and environmental monitoring data review and trending of data within established timelines.
• Developing and maintaining Key Performance Indicators (KPls) for laboratory testing.
• Delegating tasks in the department to ensure proper coverage of all required tasks in their absence.
• Participating in and tracking group budget setting and cost containment drives.
• Ensuring completion of all client QC Microbiology requirements related to GMP cellular products and/or materials.
• Interface with Regulatory Agency Inspectors/Auditors and participate in external and internal audits.
• Participate in BLA filings by providing review and compilation of Analytical data required for filings.

Supervisory Responsibility:
The Lead Laboratory Microbiologist carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions: QC Microbiology Associate, QC Microbiology Engineers, QC Microbiology Trainers, and QC Scientists.

Quality Requirements:
The Lead Laboratory Microbiologist builds quality into all aspects of their work by maintaining compliance to all quality requirements. Ensure compliance to all FDA and Worldwide Quality & Compliance regulations applicable to the job function. Attend all required Quality & Compliance training at the specified interval.

Minimum Required Training:
The Lead Laboratory Microbiologist requires Manager Training, Quality Systems Training (Deviation/CAPA/Change Control), Training in Microbial methods and Environmental monitoring in an aseptic manufacturing environment.

Requirements:
BA/BS in Microbiology or relevant field required. Biotechnology Certificate and/or cGMP experience. Minimum 7-10 years of experience with environmental monitoring or within the biopharmaceutical industry. Proficient with computer software such as Microsoft Office, MODA, and Visio. Clear understanding of compliance regulations 21 CFR 210/211, 21 CFR 610, 21 CFR 1271, 21 CFR 11, EU Annex 1, cGMPs, FDA Guidance on Sterile Drugs Produced by Aseptic Processing. Strong knowledge of microbiological test methods, philosophies, method validation, and method transfer. Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.

Salary Range: $120,000 - $180,000 per year, depending on experience.

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