Pharmaceutical Data Review Scientist
Eurofins BioPharma Product Testing North America
Summary
Ensure that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations.
Job description
Review simple and complex routine and non-routine data (for three or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; ensure all work is performed according to GLP/GMP requirements and apply GLP/GMP in all areas of responsibility as appropriate.
Perform analysis of proteins and the impurities or raw materials associated with their production using various analytical techniques.
Determine if data is compliant and defendable based on industry regulations and methodology.
Verify data is of sound quality following all method, industry, and client requirements where applicable.
Diagnose problems, solve simple problems, and suggest solutions to complex problems in professional area; perform complex calculations.
Troubleshoot method and instrumentation problems.
Use office and instrumentation specific computer software.
Produce written reports (e.g., SOP, OMC, client reports).
Requirements
- Bachelor's degree in chemistry or other related degree concentration, or equivalent directly-related experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Benefits
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- 401(k) Matching
- Paid Vacation
- Paid Holidays
Company overview
Eurofins BioPharma Product Testing North America is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide, providing comprehensive laboratory services for pharmaceutical, biopharmaceutical, and medical device companies. As a leading Contract Research Organization (CRO), the company offers extensive testing capabilities for drug substances, final products, intermediates, and starting materials for both small and large molecule drug products. Operating under GMP authorization, ISO 17025 accreditation, and ISO 9000 certification, Eurofins performs analyses according to international pharmacopeial standards including Ph. Eur., BP, USP, and JP. With over 2 million square feet of global laboratory capacity spanning 20 countries and more than 45 locations worldwide, the company maintains seven key US sites in Lancaster, PA; Portage, MI; Columbia, MO; Cary, NC; Charlotte, NC; Jacksonville, FL; and San Diego, CA. Their comprehensive service portfolio includes method development and validation, release testing, stability testing, characterization testing, residuals and impurities testing, extractables and leachables testing, viral clearance studies, and cell and gene therapy testing. The company's harmonized quality procedures, centralized LIMS, and secure 24-hour data access via LabAccess.com provide clients with consistent, reliable testing services that support drug development from early stages through commercialization.