Eurofins BioPharma Product Testing has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment.
Eurofins BPT-Columbia is looking for a Sr. Scientist to join our growing TASC (Trace Analytical Structural Chemistry) team located in Columbia, Missouri that is experienced with Extractable and Leachable programs. The Sr. Scientist is involved in planning their own work and supervising day-to-day activities in the laboratory working under prescribed procedures (protocols, standard operating procedures, methods, etc.). Completing complex work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines. Planning the conduct of a study; monitoring study procedures to ensure data accuracy and report quality; conducting complex analysis and experimentation on substances, for purposes such as product and process development and application, quantitative and qualitative analysis and improvement of analytical methodologies.
- Designs, carries out, and performs simple and complex experiments and procedures in accordance with all applicable regulatory (e.g. DEA, EPA, FDA, FIFRA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs).
- Designs procedures and experiments to complete Extractable and Leachable programs.
- Performs laboratory work daily to complete tasks as assigned.
- Routinely develops procedures and methods for the solution of technical problems.
- Performs progressively more complex procedures and experiments.
- Depending on area of assignment, handles regulated materials (quarantined matrices, DEA-controlled and radiolabeled materials, etc.), potential biohazard materials, and toxic chemicals according to company procedures.
- Likely to work on several projects concurrently and may monitor and direct activities of other staff performing work in area of expertise.
- Conducts training of staff on techniques necessary to perform laboratory assignments.
- May serve as study director, principal investigator, or project leader for GLP and CGMP studies.
- Bachelor’s degree in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas and a minimum of eight years of experience in a directly relevant setting.
- A Master’s degree in a relevant field and five years of directly relevant experience may be substituted for the bachelor’s degree and experience.
- A PhD in a relevant field and two years of directly relevant experience may be substituted for bachelor’s degree and experience. In rare cases, comparable demonstrated competence and experience in the relevant area may be used to substitute in whole or in part for the Bachelor’s degree.
Additional requirements for this position, such as skills, techniques, experience, include:
- Advanced knowledge in various analytical instrumentation, especially GC/MS and LC/MS.
- Adherence to GMP (preferred).
- Active communicate to internal and external clients.
- Desire to develop/train less experienced staff.
- Superior knowledge of scientific discipline; basic relevant technical skills; ability to read and understand protocols, SOPs, and technical guidelines.
- Compliance with, and knowledge of, regulatory guidelines and company SOPs (CGMP, GLP) is required.
- Good organizational skills; ability to follow direction and good communication skills are required.
- Ability to instruct and provide technical direction to others is required.
- Ability to consult with clients and knowledge of date submission requirements for clients is necessary.
- Mechanical aptitude is a plus.
- Superior skill in handling radioactive or toxic chemicals may be required.
- Knowledge of basic office equipment (computers, printers, faxes, copiers, etc.) is necessary.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Knowledge of laboratory statistics may be necessary.
- Ability to apply principles of scientific thinking to a complex range of intellectual and practical problems.
- Strong ability to deal with nonverbal symbolism.
- Ability to deal with a variety of abstract and concrete variables where only limited standardization exists.
- Authorization to work in the United States indefinitely without restriction or sponsorship