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
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.
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.
• 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.
1-4 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.