Senior Microbiologist

Who we are

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

The opportunity

POSITION SUMMARY
This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures. Additionally, this position will provide training and/or direction to junior analysts and function as a subject matter expert for all aspects of Quality Control Laboratory microbiology testing in compliance with cGMP and SOPs.

 

ESSENTIAL AREAS OF RESPONSIBILITY 
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation, if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

•    Responsible for scheduling and tracking analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
•    Responsible for preparing, maintaining, and reviewing thorough records.
•    Responsible for conducting investigations and root cause analysis for microbiology related deviations. Support and/or lead laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
•    Responsible for authoring and reviewing microbiological test protocols, technical reports, risk assessments, and validation documents.
•    Responsible for performing complex revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
•    Responsible for performing method suitability for compendial methods.
•    Responsible for designing and overseeing the execution of complex projects such as method transfers, validations, and regulatory reports.
•    Responsible for performing activities associated with the stability program including sampling and statistical analyses.
•    Responsible for executing projects of an advanced scope and complexity as assigned.
•    Responsible for preparing and providing training to small or large groups and leading meetings as needed. 
•    Responsible for communicating with multiple departments including manufacturing, planning, and regulatory affairs.
•    Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
•    Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. 
•    Responsible for performing additional related duties as assigned.
 

Your experience and qualifications

Education/Certification/Experience:
•    Requires a Bachelor’s degree, preferably in Microbiology or Biology, or related degree with a minimum of 7 years relevant progressive experience in a Quality Control Laboratory environment.
•    Requires working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
•    Prefer experience with Laboratory Information Management Systems (Labware LIMS).
•    Prefer some experience with validation activities.
•    Prefer experience with nonsterile pharmaceutical microbiology testing: Microbial Limits (MLT), Antimicrobial Effectiveness Testing (AET)

Skills/Knowledge/Abilities:
•    Advanced understanding of the principles of microbiology as it applies to sterilization, bioburden testing, media preparation and qualification, aseptic technique, general traditional microbiology laboratory techniques.
•    Computer proficiency with comprehensive working knowledge of MS Office products, Learning Ma