Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!
PBL has an immediate opening for a full-time Associate Director of Microbiology in the Microbiology Services Department. The Associate Director of Microbiology will be responsible for the daily operation and management of the department ensuring that the needs of Microbiology clients are met in accordance with applicable testing standards and industry regulations. The position reports to Executive Management.
THE JOB RESPONSIBILITIES FOR THE ASSOCIATE DIRECTOR OF MICROBIOLOGY INCLUDE BUT ARE NOT LIMITED TO
Lead and manage the development, implementation, and maintenance of systems in the Microbiology Services Department to ensure that Pacific BioLabs' clients receive top-notch client service from the Microbiology Services department
Maintain working knowledge of current industry standards and practices pertaining to microbiological, sterility assurance and cytotoxicity testing of pharmaceutical products and medical devices. This includes USP and European methods, as well as ISO/ASTM/AAMI guidelines
Maintain thorough knowledge and understanding of GMP's/GLP's as these pertain to work performed in the microbiology lab
Implement and maintain systems and practices that adhere to GMP's and GLP's
Function as the Microbiology Services Department representative in interactions with internal clients, regulatory agencies, collaborators, and external clients
Contribute to Business Development through active participation with Client Account Managers and inter-departmental Managers/Directors in client conference calls, study quoting/costing and visiting local Bay Area clients, as applicable;
Assume study director or analyst positions as needed
Structure and organize the efforts of department staff in all areas related to microbiology testing (equipment maintenance and calibration, test preparation, test conduct, data review, and reporting)
SKILLS AND QUALIFICATIONS FOR THE ASSOCIATE DIRECTOR OF MICROBIOLOGY
A Ph.D. in Microbiology or other relevant scientific discipline with a minimum of 6-8 years of experience required. Candidates with a Master's Degree with laboratory management experience are also encouraged to apply. Relevant laboratory management experience may substitute for an advanced degree.
Candidates with a proven record of management of scientific laboratory personnel will be given priority;
Experience in managing a small to mid-size microbiology laboratory preferred;
Broad knowledge of microbiology testing required;
Must possess critical thinking and communication skills appropriate for advanced problem solving;
Must be able to operate in a fast-past, client-centered atmosphere;
Knowledge base and experience in writing and reviewing Standard Operating Protocols (SOPs) preferred;
Must be able to analyze data and draw conclusions based on relevant guidelines and industry standards;
Local candidates preferred.