About this role
This is a laboratory-based position performing sample management, mechanical force testing, and other component/material characterization testing. Furthermore, this position may assist in data compilation, data presentations, report authoring, and department documentation support.
RESPONSIBILITIES:
The responsibilities of this position include, but are not limited to:
Work closely with other engineers in the evaluation, development, qualification and implementation of new components and container closure systemsSupport the formulation and process development groups to comply with regulatory requirements and guidance documents related to components and container closure systemsAuthor and/or review engineering and development documentation such as component drawings, specifications, assembly drawings, tolerance stack analyses, risk analyses, etc.Execute designated test methods and protocols associated with component/deviceProvide general laboratory support, including ordering/replacement of reagents and consumables, general maintenance of equipment, continuous improvement activities, and participating in periodic lab inspections.This position will be responsible for preparing data summary presentations, providing data verification support, compiling data, and using lab-based systems for data collection such as electronic laboratory notebooks.Flexibility in support of additional biotherapeutics development activities including biophysical & biochemical characterization using techniques such asHPLCCapillary Gel electrophoresis (CGE),Imaged Capillary Electrophoresis (iCE)Spectroscopy techniques, light obscuration, microflow imaging Minimum Qualifications:
Bachelor's Degree or higher in appropriate Science & Engineering disciplines, e.g. Chemistry, Biochemistry; Biomedical etc. A minimum of 2+ years relevant experience with the Pharmaceutical Parenteral Packaging DevelopmentAuthorization to work in the United States indefinitely without restriction or sponsorshipPreferred Qualifications:
• Familiarity with eLN, Bluehill Software, ISO test methods, including ISO 11040 and ISO 80369, US/EP Pharmacopoeia and other standards, regulations and guidance associated with components, container closure systems and drug delivery devices.• Strong computer skills and experience with lab-based computer systems• Familiarity with standard biotherapeutics analytical techniques such as HPLC, CGE, iCE, Spectroscopy Position is Full Time, Monday-Friday, 8am-5 pm. Candidates currently living within a commutable distance of Saint Louis, MO are encouraged to apply
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidayYearly goal-based bonus & eligibility for merit-based increasesEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.