Title:  Senior Microbiologist

Date:  Jun 24, 2022
Location:  Sun - Billerica - Plant
Company:  Sun Pharmaceutical Industries, Inc (USA)

Job Title:

Sr. Microbiologist

Job Grade:

G10

Department:

Microbiology

FLSA Classification:

Exempt

Manager’s Job Title:

Microbiology Head

Department Head Title:

EVP, Global Head, Quality & Compliance

Does This Position Have Any Direct Reports?

No

Job Description Approval Date:

 

March 2022

 

 

 

Job Summary

Oversee day to day operations of the QC Microbiology Laboratory.  Ensure that required microbiology activities related to supporting manufacturing of aseptically processed pharmaceuticals are performed in compliance with company policies and procedures and regulatory guidance.

 

  • Assure that microbiology testing for raw materials and finished product is completed to meet product manufacturing requirements for manufacture and release, including oversight of receipt of samples, testing, review and reporting of results
  • Schedule and coordinate product Sterility, Endotoxin and bioburden testing
  • Perform and or oversee endotoxin, sterility and bioburden method validations as well as other non-product related validations related to product testing and transfer.  This includes authoring, executing and completing protocols as required
  • Coordinate the microbial identification program related to environmental and utility monitoring
  • Coordinate validations of equipment and instruments supporting Microbiology Laboratory Operations
  • Coordinate outsourced laboratory testing for raw materials and product
  • Provide training for employees on functions related to QC Microbiology such as Sterility, Endotoxin, and Bioburden Testing
  • Assure that laboratory procedures are current and update applicable procedures as required
  • Assure that all activities are documented, executed and in compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP), Good Documentation Practices and company policies
  • Other duties as assigned

Work Conditions:

  • Lab
  • Office
  • Exposure to noise, bio-hazardous (live cultures), and radioactive materials and or chemicals
  • Exposure to radiation within NRC limits (monitoring badge necessary)
  • Exposure to or use of syringes and needles
  • Exposure to non-hazardous and hazardous chemicals and materials
  • Exposure to biological safety cabinets
  • Requires work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes
  • Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
  • Operate Autoclaves, depyrogenation ovens, filtration equipment, heat blocks, incubators, microscopes, cameras, Laminar Flow Hoods, Biological Safety Hoods, UV-

 

  • lights and meters, centrifugal air samplers, particle counters, radiosurvey equipment, validation equipment

Physical Requirements:

  • Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk, hear, stoop, kneel, crouch or crawl
  • Close vision; depth perception; ability to adjust focus
  • Use of repetitive motion
  • Able to operate computer/office machines
  • Lift up to 25 lbs.

 

Travel Estimate

Up to 0%

Education and Job Qualification

  • BS in Microbiology
  • Minimum 6-8 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
  • Work under minimal supervision using Standard Operating Procedures and good judgment to effectively coordinate and execute assigned activities in support of production, Quality Control and Research & Development activities
  • Knowledge of cGMP and GLP, FDA/USP requirements

Experience

  • Experience in a clean room environment required
  • Strong verbal, written and interpersonal communication with an emphasis on creating a motivated, effective working team
  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently
  • Demonstrated experience conducting investigations, writing protocols, SOP’s, validating methods, staff training,
  • Strong computer skills and proficient at word processing and utilizing spreadsheets
  • Strong industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology
  • Knowledge of microbiology (industrial), environmental, and utility monitoring and aseptic processing

Experience with sterility testing, endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification methods


Nearest Major Market: Boston