Role Summary
Senior Quality Control Scientist to join our Technical Resources Chemistry Group. You’ll mentor and supervise release, stability, in-process testing, and assay development to ensure technical excellence and regulatory compliance of QC chemistry processes.
Responsibilities
- Leading assay development, validation, optimization, and transfer processes using advanced methodologies such as HPLC, UPLC, UV spectroscopy, and other techniques.
- Reviewing and approving new test procedures and assays to ensure technical accuracy and compliance.
- Facilitating seamless assay transfers from R&D to business partners and organizing analytical assay transfers both internally and externally.
- Driving technical troubleshooting, problem investigation, and resolution for QC chemistry-related challenges.
- Reviewing technical reports, protocols, and documents for regulatory compliance and scientific integrity.
- Mentoring and training team members on systems, processes, and best practices to foster a collaborative and high-performing environment.
Qualifications
- Required: Bachelor’s degree in Chemistry, Biochemistry, or a related field with 5+ years of experience in HPLC, UPLC, and UV spectroscopy.
- Preferred: PhD in a relevant field.
- Direct experience with AAV (adeno-associated virus) is highly desirable.
Skills
- Expertise with HPLC-based assays, including UPLC and UV spectroscopy.
- Strong communication—written and verbal—and ability to present complex scientific concepts clearly.
- Ability to mentor, train, and supervise scientific staff in analytical methods and QA practices.
Education
- Bachelor’s degree in Chemistry, Biochemistry, or related field (required).
- PhD in a relevant field (preferred).