Manager of Microbiology

Overview

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions.

Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

• Provides technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing.
• Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.
• Oversight and maintenance of quality control microbiological testing program (including sterility, bioburden, identifications and Environmental Monitoring, and outsourced test laboratories).
• Participates and carries out continuous quality improvements in the QC laboratory.
• Identifies and resolves internal quality control microbiological testing issues.
• Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.
• Schedules and provides technical oversight of microbiological testing performed internally and externally sourced supporting GMP manufacturing and pre-Clinical activities and studies.
• Participates in project specific, system, client, and vendor audits.
• Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Pii SOPs, formats, and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.).
• Writes and/or reviews SOPs pertaining to Quality Control microbiological operations, STM’s (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures.
• Ensures QC microbiological laboratories and facilities are always in an audit ready status.
• Serves as a back up to QC client rep in meetings for microbiological matters.
• Acts as technical QC microbiological SME in support of client needs and projects and during third party inspections/audits.
• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
• Engages actively with Project Management and other department functions to ensure the GMP programs are properly supported to achieve expectations; maintain effective and professional communication between all parties, including the customer.
• Identifies, maintains, and reports functional KPIs to site management.
• Performs other duties as assigned.

• Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Preferred 15+ years relevant work experience in Quality Control laboratories
• Preferred three to five (10-15) years of leadership/ supervisory/management experience in commercial laboratory operations.
• 10 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)
• Experience in Analytical or Microbiological testing including Environmental Monitoring required
• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.
• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance’s (US and EU).
• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and…