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Wilmington, DE 19806
Element has an opportunity for a Microbiologist whose primary responsibility is to lead the planning, implementation, and successful completion of assigned projects in a fast paced, team environment. You will provide technical and hands on microbiology research and development support for pharmaceutical testing. In this role, you will also receive a great deal of client exposure and work on a variety of research and development projects.
+ Develops, writes, verifies, and performs microbiological test methods on a variety of products, including QC release and stability testing of marketed parenteral and other sterile and topical drug products
+ Creating and performing USP and other compendial and non-compendial microbiological test methods such as sterility testing, microbial limit testing, bacterial endotoxin testing, and preservative effectiveness testing
+ Drafting of test methods, study protocols, and reports
+ Train and develop other assigned technical staff members
Skills / Qualifications
+ Bachelor’s degree in Microbiology
+ Strong technical depth and aptitude with pharma microbiology testing is required
+ Must have 5+ years of current pharma microbiology testing in the following areas:
+ Injectable product experience
+ Sterility method development
+ Bacterial endotoxin method development and testing
+ Microbial enumeration testing
+ Must have 5 + years current working knowledge of regulatory compliance requirements, good manufacturing practice (GMP) / good laboratory practice (GLP)
+ 5+ years current hands on experience with product development & quality control testing of parenterals and other sterile drugs is required
+ 2+ years of supervisory experience leading small team of microbiologists highly preferred
+ Knowledge of relevant FDA and USP requirements/guidelines and their application to the development of various development products
+ Knowledge and experience in environmental monitoring/testing of clean rooms and aseptic processing as per GMPrequirements is highly desirable
We are Element, one of the fastest growing testing, inspection, certification and calibration business in the world.
We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.
Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.
Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.
We have four values that we strive to live by every single day.
+ Safety – We keep our colleagues and visitors safe
+ Integrity – We act honestly and fairly to do the right thing
+ Excellence – We set new standards of excellence in everything we do
+ Partnership – We work together for the benefit of our customers
When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY. We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.