The QC Manager demonstrates expert understanding of executing method validation activities in a Quality Control Laboratory. This individual will determine method validation requirements, author and/or approve method transfer and validation plans, protocols and reports. Manages internal method timelines .
The QC Manager will oversee execution of internal as well as outsourced analytical testing and analytical qualifications of exosomes, biological molecules, oligonucleotides, small molecules, and drug products. This individual will assist in building and maintaining strong working relationships with technical counterparts internally and externally. Interprets data and resolves technical issues.
- Manages internal timeline for Method Qualification/ Validation/ Verification in the Quality Control Laboratory.
- Writes and develops method validation protocols, reports and test methods.
- At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Bachelor's Degree or higher, preferred field in biochemistry, cell biology and/or microbiology or similar
- 5+ years of experience preferred managing direct reports and demonstrated ability to mentor and coach employees
- 8+ years of experience in analytical method development, analytical support of manufacturing campaigns, quality control, and method transfer.
- Ability to troubleshoot analytical instrumentation such as HPLCs/UPLCs.
- Preferred experience with DLS, NTA, ELISA, qPCR.