Sr Quality Control Scientist (Chemistry)

Role Summary

We are looking for a Sr Quality Control Scientist in the Technical Resources Department. This position performs assay development, characterization, optimization, transfer, validation, and investigations for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

Responsibilities

• Performs assay development/validation for QC.
• Reviews new test procedures and assays.
• Evaluates and bring in new methodologies/techniques when needed.
• Facilitate assay transfer from R&D and to business partners
• Organize analytical assay transfer internally and externally.
• Set product specification.
• Participates in technical troubleshooting and problem investigation.
• Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
• Participates in training programs for analysts.

Qualifications

• Required: PhD in Chemistry, Biochemistry, Biology, or a related field.
• Preferred: Experience with cell or gene therapy in a Biopharmaceutical environment.
• Willing and able to work onsite Monday-Friday, 8am-4:30pm (on-site requirement).
• Level is determined based on experience relevant to the role.

Skills

• In-depth knowledge with HPLC based assays.
• Strong written and verbal communication skills.
• Mentoring and training others on systems, processes and problem solving.
• Team player with ability to work with diverse colleagues.
• Ability to troubleshoot technical issues and adapt to changing requirements.

Education

• PhD in Chemistry, Biochemistry, Biology, or a related field (required).