EPM Scientific
Microbiology Manager
– EPM Scientific
Location: Burlington, NJ.
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 participation in customer and regulatory audits, client interactions, site metrics meetings, improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team, handling staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires working independently and collaboratively on cross‑functional teams.
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
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,
,
,
, and
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
Perform other duties as assigned
Education and 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.
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– EPM Scientific
Location: Burlington, NJ.
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 participation in customer and regulatory audits, client interactions, site metrics meetings, improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team, handling staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires working independently and collaboratively on cross‑functional teams.
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
,
,
,
,
, and
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
Perform other duties as assigned
Education and 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.
#J-18808-Ljbffr