Manager of Microbiology

  • Location: Rochester, New York
  • Type: Direct Hire
  • Job #18606

Microbiology Manager
Onsite in Rochester, NY

Company: A CRO that serves both medical Device and Pharmaceutical companies. With a focus on safety and biocompatibility, they provide assistance through the full product development life cycle, from research to release, including ISO 10993:2018 testing as well as testing programs and advisory services to support regulatory submissions.

SUMMARY:
The Manager of Microbiology, as part of the Laboratory Operations Leadership team, has overall responsibility for the Microbiology department. This position is responsible for delivering the business objectives for the Microbiology Center of Excellence by providing outstanding leadership, technical direction, and development for the Microbiology team.  

The Manager will ensure all policy, procedure, and compliance requirements and recognized industry guidance documents of the company are met (ex: cGMP, EU Annex I, ICH, PDA, ISPE, ISO).  This successful Manager will design, author, and execute more complex studies.  Additionally, the Microbiology Manager is a key customer-facing role which requires outstanding technical knowledge, project management and execution skills, and a passion for helping customers achieve their objectives. 

What you can expect to be doing…

  • Stay current with applicable regulatory and guidance documents
  • Develop or supervise the development of study protocols and reports (ex: steam sterilizers, sterilization validation – EtOH/Gamma/VH2O2, cleaning and disinfection, method suitability/validation, disinfectant efficacy)
  • Provide current technical, regulatory, and compliance expertise to staff, colleagues, and customers.
  • Review and approve data generated by other Microbiology personnel.
  • Lead and/or conduct complex studies.
  • Interface with QA, Facilities, and clients as needed.
  • Identify and manage staffing requirements and assignments.
  • Supervise technical personnel, build depth and a robust cross-training program, and appropriately delegate responsibilities.
  • Interface with clients as needed – building our client base.
  • Work with Client Services (Sales) to prepare quotes and facilitate proposal development.
  • Evaluate equipment and resource requirements.
  • Drive continuous improvement (Quality, Process, Cost, Customer Service, Technical Expertise, Technology).
  • Manage compliance with all applicable compliance/regulatory standards.

What you will bring to the table…

  • B.S. in Microbiology or a related science, M.S. preferred or appropriate combination of education and experience. 
  • Five (5) plus years relevant industry (pharma, medical device) Microbiology knowledge and experience or equivalent combination of education and experience.
  • Knowledge of cGMP/ISO/PDA/ICH/ISPE and strong documentation practices required. 
  • Three (3) plus years’ experience in supervision and management of personnel.
  • Proficiency with Microsoft Office (Word, Excel, Outlook) and programs specific to lab instrumentation.

Please reach out to Kiera@ScientificSearch.com for more information on this great opportunity! Reference Job# 18606. 

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