Microbiology Group Leader

X4 Engineering; Portage (MI); Sur place; USD 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

401(k) retirement plan with employer匹配

Paid vacation and public holidays

Résumé du poste

X4 Engineering is seeking an experienced Microbiology Group Leader to oversee our pharmaceutical microbiology laboratory operations in a regulated environment. You will lead a team of scientific professionals, ensure timely, compliant testing, and drive quality improvements across GMP-compliant processes.

The role requires deep expertise in aseptic techniques, microbial limits testing, environmental monitoring, and implementing CAPAs, audits, and investigations.

Qualifications

• Bachelor's degree in Microbiology or related life science.
• Strong knowledge of GMP/GLP and USP/ICH requirements is essential.
• Experience in pharmaceutical microbiology testing and quality control.

Responsabilités

• Lead and supervise day-to-day microbiology laboratory activities, ensuring testing is completed accurately and on time.
• Coordinate workflows, monitor productivity and implement improvements.
• Mentor and develop team members; conduct performance reviews and manage training records.

Connaissances

Leadership

Quality systems

Regulatory compliance

Team mentoring

Process improvement

Project management

Formation

Bachelor's degree in Microbiology or related life science

Description du poste

Our client is a leading global life sciences and analytical testing organisation, providing specialist testing services to support the safety, quality and compliance of pharmaceutical products and other regulated materials.

The organisation operates an extensive international laboratory network, supporting major pharmaceutical and biotechnology companies with high-quality analytical testing, scientific expertise and regulatory compliance services.

An opportunity has arisen for an experienced Microbiology Group Leader to oversee laboratory operations, lead a team of scientific professionals and ensure the consistent delivery of high-quality microbiological testing services within a regulated environment.

This role is suited to a technically strong microbiology professional with experience in pharmaceutical quality control, compendial testing, GMP compliance and team leadership.

Key Responsibilities

Laboratory Operations and Leadership

• Lead and supervise day-to-day microbiology laboratory activities, ensuring testing is completed accurately, efficiently and within agreed timelines.
• Coordinate laboratory workflows, monitor productivity and implement operational improvements.
• Supervise routine and non-routine testing activities in accordance with applicable technical procedures and quality standards.
• Develop, coach and mentor team members, supporting technical development, performance improvement and succession planning.
• Conduct performance reviews, participate in recruitment and maintain employee training records.
• Address performance concerns, foster team engagement and promote a culture of accountability and continuous improvement.
• Monitor employee time records and ensure compliance with relevant employment regulations and company policies.

Technical and Regulatory Oversight

• Ensure laboratory activities comply with applicable Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), quality systems and regulatory requirements.
• Maintain a strong understanding of relevant United States Pharmacopeia (USP), International Council for Harmonisation (ICH) and European Pharmacopoeia (Ph. Eur.) requirements.
• Support the implementation and maintenance of quality policies, identifying and addressing deviations from established procedures.
• Lead and support laboratory investigations, including complex investigations requiring independent technical judgement.
• Support audit preparation, client audits, regulatory inspections and the development of appropriate responses to findings.
• Provide technical guidance across microbiology testing disciplines, supporting colleagues and other laboratory teams as required.

Continuous Improvement and Business Performance

• Identify and implement initiatives to improve laboratory efficiency, quality, productivity and operational performance.
• Lead or contribute to Lean initiatives and continuous improvement programmes across the laboratory and wider organisation.
• Assess laboratory requirements for equipment, technology, staffing, space and future operational capacity.
• Monitor key performance indicators and contribute to resource planning and cost management.
• Support the evaluation of testing services, pricing catalogues and complex project requirements.
• Participate in client discussions and provide technical leadership for complex projects and escalated issues.

Required Technical Experience

Candidates must have practical experience in at least two of the following pharmaceutical microbiology testing disciplines:

• USP <61>, <62> and/or <60>: Microbial enumeration, specified microorganisms and microbiological examination of non-sterile products.
• USP <51>: Antimicrobial effectiveness testing.
• USP <71>: Sterility testing.

Candidates should also demonstrate:

• Extensive knowledge of aseptic techniques, microbial limits testing, endotoxin testing, sterility testing, environmental monitoring and microbial identification.
• Experience working within a GMP-regulated pharmaceutical or life sciences laboratory.
• A strong understanding of applicable compendial methods and regulatory expectations.
• Experience conducting laboratory investigations, identifying root causes and implementing corrective and preventive actions.
• The ability to interpret technical requirements and make sound, evidence-based decisions.
• Experience training, mentoring or supervising scientific staff.

Qualifications and Experience

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry or a related scientific discipline.
• Demonstrable experience in pharmaceutical microbiology, microbiological quality control or a closely related regulated testing environment.
• Previous experience leading, supervising or developing a technical laboratory team.
• Strong communication, organisational and problem-solving skills.
• Ability to manage competing priorities while maintaining high standards of quality, compliance and customer service.

Personal Attributes

The successful candidate will be a proactive and technically credible leader who can balance hands‑on scientific knowledge with people management and operational accountability.

They will demonstrate a commitment to quality, continuous improvement and customer satisfaction, alongside the ability to influence colleagues, resolve complex technical issues and prepare a laboratory team for future growth.

The organisation offers a comprehensive benefits package, including:

• Medical, dental and vision insurance options.
• Life and disability insurance.
• 401(k) retirement plan with employer matching.
• Paid vacation and public holidays.

The Opportunity

This is an opportunity to join an established life sciences testing organisation in a leadership position with responsibility for laboratory performance, technical quality, team development and continuous improvement within a regulated pharmaceutical microbiology environment.