Sr. Quality Control Scientist

About the role

This position involves performing 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 and can work with a variety of different people on different tasks.
• Has strong written and verbal communication skills.
• Enjoys mentoring and training others on systems, processes and problem solving.
• Enjoys 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.
• Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred.
• PhD is preferred.

Skills

• Strong analytical skills.
• Excellent problem-solving abilities.
• Effective communication skills.
• Ability to work independently and as part of a team.
• Knowledge of regulatory guidelines and standards.

Benefits

Includes a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$78,700.00 - $128,700.00 annually

Schedule

Full-time