D4 - Associate Scientist
- Front room FDA/Inspectional experience on systems, QEs, method transfers etc.
- Performs investigations for OOS, data analysis for method transfers and process investigations, assists in troubleshooting lab procedures and taking required corrective actions
- Provide the technical expertise in support of method transfer/ validation activities for the QC network or for ongoing incoming release and stability testing.
- Ability to work across intra and inter functional departments to achieve alignment of company objectives.
- Reviews or writes technical reports and perform data analysis and trending for both method transfers and investigations.
- Recognize and troubleshooting of analytical method excursion. Provide guidance for equipment troubleshooting as needed.
- Trains less experienced analysts on basic and complex test methods.
- Peer review/ approval of lab data generated as a part of method transfer/ validation activities or for ongoing incoming release and stability testing.
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences
- Minimum of 4 years (MS)/ 6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
- Proficiency (or mastery) of Separation technology [chromatography], technical knowledge/SME in a technical discipline
- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
- Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices
- Strong expertise in one or more disciplines, operational knowledge of analytical instruments to support ; familiar with method validations and procedures and method development history; proficient in lab software application such as LIMS, SmartLab, etc.
- Knowledge of US/EU Requirements and industry best practices; develops strategies for solving complex problems/issues with coaching