Microbiologist Lead/Supervisor

Title: Microbiologist Lead/Supervisor

Location: Piscataway, NJ

Hours: Monday- Friday 8:00am-5:00pm

Type: Direct Hire

Overview:

Microbiologist to execute department strategy and work projects. Will be the Microbiologist Subject Matter Expert (SME) for the department, responsible for scheduling microbiological testing, releasing of product and testing for validation protocols. Will also be responsible for guiding and instructing team on daily duties, scheduling work hours for the team.

Responsibilities:

• Coordinates microbiological testing, release of product and testing for validation protocols.
• Performs organism identification.
• Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests.
• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
• Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
• Performs other functions as required or assigned
• Complies with all company policies and standards
• Other special projects and/or duties may be assigned by Management.
• Trains other Microbiologist on Department methods, process and procedure
• Works with other departments to accomplish Company goals or projects.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and/or correspondence.
• Ability to communicate effectively in the QC groups or other department in the organization.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Requirements:

• BS or MS in a scientific discipline or equivalent
• Minimum of 10 years' experience in a Microbiology Lab within a GMP pharmaceutical facility
• Lead or Supervisory experience in a pharmaceutical Microbiology Laboratory
• Willingness to be hands on in lab when needed
• Microbiology testing including endotoxin testing, bioburden/ microbial limits testing or equivalent), water testing, water sampling, environmental monitoring (settle plates, SAS or RCS (or equivalent), RODAC/ Contact sampling, NVPC).
• EM (Environmental Monitoring)
• Strong experience with Aseptic Techniques
• Experience with WFI sampling (water for injection sampling) "water testing"
• Experience with Veeva Vault expected
• Experience with Autoclave expected