Manager, Microbiology

At Proclinical, we are seeking a talented individual to fill the role of Manager of Microbiology, based in San Francisco, CA. The successful candidate will provide technical experience, troubleshooting and support to the site, as well as all onsite personal aspects/issues.

Responsibilities

• Manage a team within the QC Microbiology department involved in the validation, testing and review of raw materials, intermediates (in process) and drug product testing in a cGMP regulatory environment.
• Responsible for all QC microbiological aspects of cGMP compliance and review of sample analysis.
• Provide, review and make recommendations for environmental trending and monitoring data for site personnel and management.
• Support manufacturing personnel and other departments as required in the identification of microbiological root cause analysis.
• Provide technical microbiological support and advice on QC related topics as needed.
• Provide knowledge of sterility testing using specialized equipment and diagnostic microbiology.
• Review and approve investigations, SOPs and reports.
• Oversee laboratory investigations.
• Ensure CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
• Participate in inspections for regulatory/internal/corporate audits.
• Present micro data reports clearly and concisely to senior management, including QC performance metrics and trends.
• Proactively identifies and implements improvements and lean initiatives.
• Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
• Contribute to the development of department budget and provide sound financial stewardship, management and control
• Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.

Skills And Qualifications

• Degree in a relevant scientific discipline, and 8+ years of related industry experience.
• Excellent written, verbal, and interpersonal communication skills.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 - 20 lbs and lift up to 50 lbs.
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to various hazardous materials.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 6465420152 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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