Manager Microbiology – Pharma Manufacturing

2 months ago

Lawrence, United States Management Recruiters of Edison Full time

Our client – a growing company with multiple plants in the US, needs a Manager of Microbiology at their plant expanding to manufacture pharmaceutical products . Excellent salary up to $120K + Relocation Assistance + Full Benefit Package + 3 Weeks’ vacation.

Job Posting # 2653

Job Title : Manager Microbiology – Pharma Manufacturing Location: Lawrence, KS

Compensation: Salary of $100K - $120K per year

Relocation: YES - Client offers relocation assistance and payments for expenses

Benefits: Full package for medical, dental insurance, 401K + 3 Weeks’ Vacation + 13 days - PTO, etc.

This is a privately held company in business for 40 years with 300 people at manufacturing sites in CA, KS

Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing .

The new operation expansion is for Pharma - Blow Fill Cap – BFC of Sterile Solutions.

The Quality group has around 25 people from QC, QA, Microbiology, Quality, Validation, Compliance. This role will report to the Director of Quality .

This Manager will have a group of 3 including Lead Microbiologist + Microbiologist



Job Summary:

● Microbiology Manager will manage and monitor day-to-day activities relating to the environmental quality processes and practices at the site applicable to the company’s regulatory and statutory requirements.

● This position provides technical support and leadership as the Environmental Quality SME by developing, validating, coordinating, and trending routine and special testing of environmental monitoring, sterility, endotoxin, and particulates.

● The position requires experience in the development of facility environmental monitoring and personnel monitoring programs.

● The incumbent will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Director.

● The incumbent is responsible to follow company policies, cGMP’s, and all Standard Operating Procedures as mandated for this position.

Job Description:

● Provide technical knowledge and leadership for sterilization processes in conjunction with support in resolution of plant challenges, method development and project work.

● Establish and manage testing schedules for timely release of products and materials in alignment with the business goals and priorities.

● Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory and statutory requirements.

● Act as the site EQ technical lead for internal / external stakeholders, regulatory inspections and / or any other business requirements.

● Establish and maintain certification procedures for test methods and for testing personnel.

● Support activities as assigned by Quality Leadership to facilitate testing, qualification, system improvements and compliance [Change Controls, CAPA, Out of Specification (OOS), Validation documents, Laboratory Investigations, Standard Operating Procedures].

● Provide oversight and technical knowledge to ensure proper microbiological monitoring of plant utility systems, including routine trend analysis.

● Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial, and sterilization challenges for the site and the QC Lab.

● Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.

● Operate in compliance of cGMP, 21CFR and USP regulatory requirements.

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