GC/MS Scientist- Extractables & Leachables

The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds that may pose health risks to the patient. This individual will: Perform various tasks and analyses of Bio/pharmaceutical ingredients and products with a high degree of accuracy and precision; Review/prepare standards and samples for analysis and running a variety of equipment or instrumentation independently; Troubleshoot and solve instrumental and/or method problems; Work efficiently, proactively, and productively; Ensure that client receives quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations; Evaluate current systems and suggest process improvements when appropriate; Write complete and detailed investigations independently; Support multiple projects simultaneously; Demonstrate leadership qualities and train newer analysts.

Responsibilities

Perform various tasks and analyses of Bio/pharmaceutical ingredients and products with a high degree of accuracy and precision; Review/prepare standards and samples for analysis and running a variety of equipment or instrumentation independently; Troubleshoot and solve instrumental and/or method problems; Work efficiently, proactively, and productively; Ensure that client receives quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations; Evaluate current systems and suggest process improvements when appropriate; Write complete and detailed investigations independently; Support multiple projects simultaneously; Demonstrate leadership qualities and train newer analysts

Requirements

Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration; Authorization to work in the US indefinitely without restriction or sponsorship; 1 year of GMP laboratory experience; 1 year of experience with GC/MS in industry

Nice to have

Experience operating GC/MS and/or ICP systems; Experience with extractables and leachables testing; Experience with ISO 10993 and/or ISO 18562 testing; Experience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab; Experience with method development and validation; Experience identifying unknown compounds by mass spec; Polymeric experience/education

Benefits

Excellent full time benefits including comprehensive medical coverage, dental, and vision options; Life and disability insurance; 401(k) with company match; Paid vacation and holidays