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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 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.

Candidate Must Have:

• Bachelor’s Degree
• Min. 8 years of Quality experience in FDA regulated Pharma or Medical Devices
• Min. 3 years of Quality Management experience
• Excellent people, communication and management skills to create a team environment
• Good leadership skills to motivate plant personnel and gain their respect

• Working knowledge of 21 CFR Parts 210, 211 and 820 FDA compliance
• Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.
• Technical knowledge of pharmaceutical manufacturing.
• Able to work effectively in a customer service and business partner role

Candidate Nice to Have:

• Technical degree in Science, Chemistry, Biology, Microbiology or Engineering

• Certified Quality Auditor certification, or equivalent.

• Experience with remediation of Quality systems in FDA 483, warning letter, or Consent Decree.
• Audit or inspection experience preferred.
• Startup or Small company experience working in a dynamic and hands-on role.
• Familiarity with Quality Management Systems.
• Knowledge of Sterile Aseptic Filling Operations
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, Microbiology, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant,