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: A PhD in Chemistry, Biochemistry, Biology, or a related field.
• Required: Willing and able to work onsite Monday-Friday, 8am-4:30pm.
• Preferred: Experience with cell or gene therapy in a Biopharmaceutical environment.
• Required: In-depth knowledge with HPLC-based assays.
• Required: Strong written and verbal communication skills.
• Required: Ability to mentor and train others on systems, processes and problem solving.
• Required: Team-oriented with ability to collaborate across tasks and teams.
• Required: Ability to work in a fast-paced environment and adapt to changing requirements.
• Required: Willingness to take on new and sometimes ambiguous challenges and learn quickly.

Skills

• HPLC-based assay development and validation
• Technical troubleshooting and problem investigation
• Analytical development review and regulatory compliance awareness
• Training and mentoring of analysts
• Effective written and verbal communication
• Cross-functional collaboration with R&D and business partners

Education

• PhD in Chemistry, Biochemistry, Biology, or a related field

Additional Requirements

• Onsite work Monday-Friday, 8am-4:30pm