Sr Quality Control Scientist

Role Summary

Senior Quality Control Scientist to join the Technical Resources Chemistry Group, shaping assay development, optimization, validation, and transfer processes for the QC Chemistry team. Provides mentorship and supervision for release, stability, in-process testing, and assay development, ensuring technical excellence and regulatory compliance.

Responsibilities

• Leading assay development, validation, optimization, and transfer processes using methods such as HPLC, UPLC, UV spectroscopy, and related techniques.
• Reviewing and approving new test procedures and assays to ensure technical accuracy and compliance.
• Facilitating assay transfers from R&D to business partners and organizing analytical assay transfers internally and externally.
• Driving technical troubleshooting 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

• Bachelor‚Äôs degree in Chemistry, Biochemistry, or a related field with 5+ years of experience in HPLC, UPLC, and UV spectroscopy.
• A PhD in a relevant field is strongly preferred.
• Direct experience with AAV (adeno-associated virus) is highly desirable.

Skills

• Expertise with HPLC-based assays, including UPLC and UV spectroscopy.
• Strong written and verbal communication; ability to present complex scientific concepts clearly.