Quality Control Associate Scientist
The Quality Control Associate Scientist will lead the execution of technical transfer and co-validation activities for the QC network; and support QC operations with equipment/ method troubleshooting.
- Write, Review and Approve technical protocols and reports.
- Recognize and recommend solutions for instrumentation and method issues.
- Work independently on testing and methods including data review and demonstrated ability to recognize anomalous trends or results.
- Peer review/ approval of lab data generated as a part of method transfer/ validation activities.
- Support implementation of analytical method change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
- Skilled at authoring validation protocols and final reports;
- Works according to cGMP requirements and HA expectations.
- Responsible to lead complex major/critical QEs, drive effective root cause and CAPA, provide rationale and justification for changes to requirements for ongoing investigations. Provide training and expertise on investigational techniques. Expert in Root Cause analysis
- Lead the equipment qualification and decommissioning of QC equipment as per BMS procedures.
- Knowledge of science generally attained through studies resulting in a BS/ MS 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 of Separation technology [chromatography], A280 and Karl Fisher analysis; 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
- Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
- Demonstrated several successful and sustainable method tech transfer, ability to conduct multiple projects independently; recognized as expert in 1 or more technical areas and applies broad expertise in technical matters.
- Proficient in all compendial requirements. Evaluates new technologies for QC use. Have ability to recognize instrumentation and method issues and provide recommendation on instrument and method improvements.
- Knowledge of US/EU Requirements, Corporate Directives and industry best practices; develops strategies for solving complex problems/issues; recommending and driving implementation of solutions
- Front room FDA/Inspectional experience on systems, QEs, method transfers etc.
- Ability to work across intra and inter functional departments to achieve alignment of company objectives.