Toxikon a premier product testing service and development organization in the world, serving all domestic and internationally regulated market segments. Toxikon located in Bedford MA, is looking for a Senior Microbiologist.
Responsible for the analysis of packaging components, raw materials and finished products using proscribed analytical procedures.
Conducting routine and non- routine product testing including USP/EP Sterility testing, Bioburden testing, Water testing, and Biological Indicator testing per TOXIKON SOPs.
Performing all tasks associated with Microbial Identification and Environmental Monitoring.
Working in accordance with all internal and external regulatory bodies including GMP, ICH, and TOXIKON SOP's.
Supervising and managing of a GLP/GMP microbiology laboratory, including maintenance of equipment, lab supplies as well as general lab organization.
Review all test documentation. Initiate and revise SOPs, protocols and final reports.
Organizing your work to accommodate simultaneous testing of several samples and effectively communicate your results.
MS or Ph.D. in Microbiology.
3+ years related experience in a regulated microbiological testing or product development environment.
Strong knowledge in compendial methodologies (AAMI, USP, others) and techniques as well as medical device microbiological and sterilization testing requirements.
Knowledge of FDA GLP and GMP regulations required, in addition to strong training and supervisory skills.
TOXIKON offers a complete benefits package including paid vacation; 401(k) plan, medical, dental and life insurance benefits; health and dependent care reimbursement accounts. We are an equal opportunity employer.
If interested please forward your resume to recruiter at toxikon.com Attn: JTR or FAX to 781-271-1137
15 Wiggins Avenue
Bedford, MA 01730
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