Job Description
The Microbiologist III is critical to the Microbiology group and the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute.
Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile pharmaceutical dosage forms, and general support activities within the Microbiology group in the Quality Control Department. An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs. The individual will author and/or revise procedures/methods, as appropriate.
II. Essential Functions:
Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.Function as a group lead, and provide technical guidance to junior analysts.To maintain awareness of cGMPs, industry standards, modern techniques and their application to pharmaceutical sciences activities.Author and/or revise procedures/methods, as appropriate.Perform technical review and verification of peers analytical data in accordance with SOPs.Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities.Function as a back-up to the manager, as needed.III. Position Requirements:
Education or Equivalent: Bachelor's degree in chemistry or closely related physical science.
Experience::
Education: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience
OR-Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience
Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.Knowledge/Skills Requirements:
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPsAbility to learn and retain technical informationProactively address work issues at both an individual level and a team levelExecutes procedures or methods of moderate complexity with high qualityAbility to interpret a variety of instructions furnished in written, oral, diagram, or schedule formMathematical and scientific reasoning abilityBasic understanding of instrument operations and troubleshooting skills in multiple techniquesAbility to identify aberrant/out of spec data and limited interpretation of data expectedExcellent written and verbal communications skills with internal and external customersTarget pay $36-43/hr commensurate with experience
