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Director/ Senior Manager Microbiology

Employer
The Tidewater Group
Location
Hagerstown, Maryland, US
Salary
Competitive
Closing date
Dec 29, 2021

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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WOULD THIS BE OF INTEREST TO YOU

WE are currently looking forDirector/ Senior Manager Microbiology

in Maryland.

for a world class firm .-IF THE POSITION IS OF INTEREST OR IF YOU KNOW SOMEONE-PLEASE SEND A CURRENT RESUME:john@tidewater.org

or call 727-441-1305

e with cGMP FDA requirements.

BASIC FUNCTION:

Manage the daily operations for the microbiology and raw materials testing laboratory to support drug product manufacturing. Maintain routine environmental monitoring, clean utilities and cleaning verification programs. Support internal corporate audits as the microbiology subject matter expert within the Microbiology department. Oversee and monitor trending reports for microbial programs. Oversee qualification/verification of analytical test methods and instrumentation including supporting documentation, procedures, protocols and reports. Anticipate performance issues and troubleshoot complex technical problems. Conduct OOS and microbial testing laboratory investigations. Act as subject matter expert for internal/external deviations, CAPAs. Identify and implement continuous improvement projects for lab process efficiencies. Perform routine maintenance of laboratory equipment. With guidance from Senior Management, establish the Microbiology team annual goals. Train and mentor laboratory personnel in basic and complex laboratory techniques. Work on assigned projects independently with limited supervision.

RESPONSIBILITIES: • Ensure laboratory compliance with current Good Manufacturing Practices (cGMP), USP, EU and other global regulatory requirements at all times, and have a deep understanding of USP, EP,JP, and FDA microbiology testing requirements. • Influence routine testing strategies and sampling requirements in support of regulatory submissions. • Act as a technical lead on microbiology test validations and method qualifications. • Responsible for maintaining the laboratory test schedule for all microbiology activities and delivery of results within established batch release timelines. • Central point of contact for all microbiology-related inquiries. • Identify and execute continuous improvement projects for the department. Lead and develop best practices in the laboratory. • Interface with Regulatory Agency Inspectors/ Auditors and Client Inspectors/ Auditors.

REQUIREMENTS: • Working independently, carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. • Using technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department. • Initiate and perform Deviation Investigations/CAPA's associated with Microbiological tesing. • Perform other duties as assigned.

QUALIFICATIONS: • BS/BA or MS/MA degree in the biological or chemical sciences with an emphasis on microbiology. • 10-12+ years of related laboratory experience in the operation of a microbiology testing laboratory • 3-5+ year prior personnel management or supervisor experience • Experience in routine environmental monitoring and data trending programs • Ability to perform complex laboratory and troubleshooting procedures without technical supervision • Demonstrated knowledge of and ability to apply cGMP regulations; prior interactions with domestic an international regulatory agencies • Ability to effectively work in cross functional team within the organization.
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