Manager of Microbiology

Jabil•Hunt Valley, MD

39d

About The Position

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. The Manager of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including but not limited to testing function in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Manager assures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Manager identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Manger keeps Head of Quality informed of all departmental activities and product-related events.

Requirements

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 subordinates.
Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
Must be able to comprehend and follow all applicable SOPs.
Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
Good understanding of cGMPs, industry, and regulatory standards and guidelines.
Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
Demonstrate the ability to portray the appropriate level of integrity and professionalism.
Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results-oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
Demonstrate the ability to work well in a cross-functional team environment.
Must communicate fluently in English and have legible handwriting.

Responsibilities

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.
Engage 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.
Identify, maintain, and report functional KPIs to site management.
Perform other duties as assigned.