Lead Microbiologist - Pharmaceutical - QC

Our client - a global company with multiple plants in the US, needs a Lead Microbiologist - Pharma - QC at a growing plant expanding to manufacture pharmaceutical products. Excellent salary + Sign on Bonus for Relocation + Full Benefit Package.

Job Posting # 2580R

Job Title: Lead Microbiologist - Pharmaceutical - QC Location: Lawrence, KS

Compensation: Salary of $60K - $80K per year

Relocation: YES - Client offers relo assistance as a Lump Sum allowance for all expenses

Benefits: Full package for medical, dental insurance, 401K, etc.

Our client is a privately held group of global companies in business for 40 years with 1,400 people. They have 4 major manufacturing sites in CA, TX, KY and 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 Fill Finish Seal - FFS of Sterile Aseptic liquids.

This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance. This role will be responsible for all the Environmental Testing and will report to the QC Manager.

Job Summary:

The Lead Microbiologist manages and monitors day-to-day activities relating to the environmental quality processes and practices at the site to applicable company, regulatory and statutory requirements.

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

The position will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Control (QC) Manager.

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

Note 1: This is a senior Lead level role but without any direct reports.

Note 2: Extensive years of related Quality experience will be considered in place of a BS degree

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 lead 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 QC Management 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:

Bachelors of Science in Microbiology or relate science field.
5 years of QA/QC experience
1 year of Supervision experience
2 years of experience in Medical Device or BioPharma- FDA regulated IndustryFlexibility and ability to manage multiple and competing priorities.
Ability to multi-task with strong sense of urgency; ability to meet deadlines.
Self-motivated, dependable, well organized.
Able to communicate effectively and efficiently, both orally and in writing.
Must hold excellent problem-solving skills.
Excellent attention to detail and capable of performing dependable, accurate work.

Candidate Nice to Have:

Knowledge of Sterile Aseptic Filling Operations
Startup or Small company experience working in a dynamic and hands-on role.
Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, FDA, QA, QC, CMO, Environmental, testing, Quality Control, Sterile Aseptic, filling, FFS, Microbiologist,