About this role
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 precisionReview/prepare standards and samples for analysis and running a variety of equipment or instrumentation independentlyTroubleshoot and solve instrumental and/or method problemsWork 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. Minimum Qualifications:
Bachelor's degree in chemistry, biology, biochemistry, or related degree concentrationAuthorization to work in the US indefinitely without restriction or sponsorship2 years of GMP laboratory experience1 year of experience with GC/MS in industryPreferred Qualifications:
Experience operating GC/MS and/or ICP systems. Experience with extractables and leachables testingExperience with ISO 10993 and/or ISO 18562 testingExperience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab. Experience with method development and validationExperience identifying unknown compounds by mass spec. Polymeric experience/education Working schedule will be Full-Time, M-F 8am-5pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. No relocation assistance will be given. 25% travel may be required. This position is NOT remote.
What we Offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.