Senior Lab Manager

Job Description

Job Description

Salary : $120,000 - $150,000

The Senior Lab Manager oversees all aspects of assigned testing procedures, ensuring accurate analysis, interpretation, and documentation of results.

As the single point of control for studies, the Senior Lab Manager ensures compliance with regulatory standards while managing the microbiology laboratory's daily operations to uphold high-quality standards.

This position is on site.

Key Responsibilities :

• Lead a team of QC microbiology professionals, ensuring technical precision and quality in all lab operations including sample management, testing schedules, microbial isolation, equipment maintenance, and inventory control.
• Provide mentorship and guidance to foster a culture of continuous improvement and excellence among staff.
• Serve as the primary contact and subject matter expert (SME) for customer inquiries regarding testing services.
• Oversee and perform routine QC testing such as bioburden, endotoxin, B&F testing, microbial ID analysis, preservative efficacy, and raw materials testing.
• Plan and manage water and environmental monitoring sampling in alignment with testing and manufacturing activities.
• Implement corrective actions in response to environmental monitoring excursions.
• Develop, maintain, and review QC testing procedures, including the creation and oversight of SOPs, protocols, and reports according to ISO 13485 QMS.
• Ensure compliance with Good Manufacturing Practices (cGMP) in all documentation and testing processes.
• Lead continuous improvement initiatives and ensure the QC team meets KPIs.
• Play a key role in preparing for and participating in regulatory inspections.
• Ensure data traceability and accuracy throughout the testing process, acting as the final sign-off for assigned studies.

Regulatory Compliance :

• Stay current with applicable regulatory requirements (GMP, GLP, ISO, etc.) and company policies.
• Ensure analysts follow approved test procedures, accurately record data, and take corrective actions when needed.
• Collaborate with sponsors, providing timely testing updates and ensuring their expectations are met.
• Work with cross-functional teams, including Quality Assurance and Sales, on testing quotes and organizational goals.
• Ensure that analysts are properly trained in the necessary testing procedures.

Technical Expertise :

• Extensive experience in microbiology, with a focus on pharmaceutical, biotechnology, or medical device products.
• Proficient in laboratory testing, equipment management, and quality control.
• Strong leadership experience in a QC laboratory setting.
• Ability to troubleshoot, solve problems, and make informed decisions.
• Excellent attention to detail, documentation skills, and proficiency in Microsoft Office and lab systems.

Professional Skills :

• Strong communication skills, both verbal and written.
• Exceptional organizational skills with the ability to manage multiple tasks and meet deadlines.

Work Environment :

• Operates in a professional lab setting, using standard office and laboratory equipment (e.g., microscopes, pipettes, computers).
• Occasional local or overnight travel may be required.

Physical Requirements :

• Regular movement throughout lab and office areas, including standing, bending, and using various lab tools.
• Must be able to wear appropriate personal protective equipment (PPE) such as lab coats, goggles, gloves, and face shields as required.

Qualifications :

• Bachelor’s degree in Biology or a related field.
• 5-10 years of experience in ISO 17025 / 13485 Microbiology laboratory settings in a technical management role.
6 days ago