Manager, Microbiology

Job Title: Microbiology, Manager

Location: Albuquerque, NM

Summary:

The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. This individual serves as the subject matter expert on contamination control and microbiological testing of parenteral drug products. The role involves significant participation in customer and regulatory audits, client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams.

Essential Duties and Responsibilities:

• Develop and maintain leader standard work in the laboratory
• Align and maintain staff shift schedules with required manufacturing support functions
• Demonstrate expertise in CGMP guidelines, ISO 17025, and USP microbiological testing, especially USP <51>, <61>, <62>, <71>, <85>, and <1116>
• Maintain laboratory policy and procedure manuals; assist in developing and validating procedures and document preparation
• Ensure timely completion of projects, CAPAs, and investigations
• Manage, conduct, and/or delegate the final review and approval of environmental and microbiological test results, including those from contract labs, to support lot disposition and deliverables as prioritized by site leadership
• Oversee compliance guideline reviews, industry trend assessments, customer projects (method transfer, development, etc.), validation efforts, expansion projects, and continuous improvement initiatives
• Act as SME to lead collaboration between departments to trend and continuously improve site Contamination Control Strategy and Environmental Monitoring Program
• Represent the department during regulatory, customer, and internal audits; ensure timely response to audit observations and execution of related CAPAs
• Develop and execute training on laboratory methods, instrumentation, and aseptic technique
• Build and evolve the department Training Matrix to align with industry standards and best practices
• Write and revise Microbiology and other relevant SOPs as required
• Provide technical input on product testing issues and instrumentation/equipment
• Ensure laboratory compliance with cGMP through inspections of monitoring systems and equipment
• Ensure proper recording and review of data
• Test the integrity of raw materials or finished products
• Conduct and document failure and complaint investigations
• Serve as liaison to service, calibration, and technical representatives
• Facilitate revision and release of controlled documents
• Facilitate mandatory reviews of SOPs and month-end reports
• Provide oversight for projects to update/maintain official document templates
• Direct and manage the Change Control System
• Read and interpret SOPs to ensure compliance
• Maintain up-to-date training records
• Perform other duties as assigned

Education and/or Experience:

• Bachelor's Degree in Microbiology or related field
• Minimum of five (5) years of experience in microbiology or related field within a GMP-regulated environment
• Minimum of two (2) years of experience in a microbiology leadership role
• Previous experience with pharmaceutical cleanroom environments
• Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements

Preferred Experience:

• Five (5) years of experience in a microbiology leadership role
• Five (5) years of microbiology laboratory experience within a GMP-regulated setting

Supervisory Responsibilities:

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. It also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills are essential, along with effective presentation skills to successfully present information and respond to questions from managers, clients, customers, and the general public.