Principal Quality Control Scientist (Chemistry)

About the role

This position performs assay development, characterization, optimization, transfer, validation, and investigations for Quality Control (QC).

Responsibilities

• Performs assay development/validation for QC.
• Reviews new test procedures and assays.
• Evaluates and brings in new methodologies/techniques when needed.
• Facilitate assay transfer from Research & Development (R&D) and to business partners.
• Organize analytical assay transfer internally and externally.
• Set product specifications.
• 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.

Requirements

• In-depth knowledge with HPLC based assays.
• Likes dealing with technical issues, troubleshooting, and constant change.
• Works well as a team player, able to work with a variety of different people on different tasks.
• Strong written and verbal communication skills.
• Enjoys mentoring and training others on systems, processes and problem solving.
• Enjoy working in a fast-paced environment and is flexible to changing requirements.
• Can take on new and sometimes ambiguous challenges and learn quickly.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related field.
• 6+ years of relevant experience.
• Higher level degree preferred.
• Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred.

Skills

• Strong analytical and problem-solving skills.
• Excellent organizational and attention to detail skills.
• Ability to work independently and as part of a team.
• Proficiency in laboratory equipment and techniques.

Benefits

Regeneron offers a comprehensive benefits package, which varies by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

For additional information about Regeneron benefits in the U.S., please visit here.

For other countries specific benefits, please speak to your recruiter.