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Manager of Microbiology

Company: LNK International
Location: Hauppauge
Posted on: November 23, 2022

Job Description:

MANAGER OF MICROBIOLOGY We started our journey with one objective: to help protect human life and today, LNK International is a growing OTC pharmaceutical manufacturer with several locations in Hauppauge on Long Island. We seek an experienced . Manager of Microbiology _Job Description_The Manager of Microbiology is responsible for providing daily management of microbiology lab operations (people, process, product) within Quality Control. The successful candidate's title will be contingent on their education & experience.The candidate will contribute to testing/reviewing QC Microbiology-related data, develop environmental and utility monitoring programs and lead QC Microbiology-related activities such as investigations, CAPAs, and change controls to assure adherence to regulations and client expectations._Primary Responsibilities_Provide subject matter expertise for and implement Quality Control Microbiology programs, test methods, and strategies for newly built cleanrooms in the cell therapy manufacturing facility.--- Lead and provide expertise for growth promotions and microbial identification.--- Schedule environmental monitoring, utilities, in-process and final product testing including data review/approval.--- Generate, review, and/or approved QC Microbiology study protocols and reports for Environmental Monitoring Performance Qualification and Aseptic Qualification.--- Conduct and manage QC Microbiological activities related to risk assessments, deviations, investigations, change controls, CAPAs and audits.--- Select, develop/train, supervise and evaluate microbiology staff to ensure site objectives are met.--- Participate in the development and implementation of information technologies that support documentation and data management systems ensuring patient supply.--- Represent QC in cross-functional teams, projects, and GXP-related problem resolution._Qualifications_--- Bachelor's Degree in a scientific discipline.--- 8+ years of experience in cGMP-regulated biotech/pharmaceutical industry.--- Minimum 2 years of leadership experience as a manager.--- Thorough knowledge of cGMP/I CH/FDA regulations and IS05, IS07and IS08 environments.--- Clean room and manufacturing environment experience required.--- Experience in design and execution of instrument qualification and validation utilized in QC Microbiology.--- Knowledge of QC Microbiological rapid testing methodologies preferred (e.g. BacT 3D ALERT system).--- Ability to independently prioritize/manage activities for self and direct reports.--- Proficient in MS Office applications and information technologies that support documentation and data management systems.Direct Reports1-4 direct reports. May also act as a team lead for facility/client projects.We seek an exceptional team player with strong interpersonal skills and the ability to operate effectively in a fast paced, deadline driven environment.LNK International is an equal opportunity employer offering a comprehensive benefits program._ Please send resume for immediate consideration. __EOE m/f/d/v_Job Type: Full-timeBenefits: 401(k) Dental insurance Health insurance Paid time off Vision insuranceSchedule: 8 hour shiftWork Location: One location

Keywords: LNK International, Stamford , Manager of Microbiology, Executive , Hauppauge, Connecticut

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