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Scientist, Analytical Development Specialist

2 months ago


Waltham, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time
Job Overview

This position seeks a passionate analytical scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.

Key Responsibilities
  • Lead analytical technology transfers, collaborating with teams and mitigating risks.
  • Validate analytical methods following regulatory guidelines for accuracy and precision.
  • Ensure analytical activities comply with regulatory standards and prepare submissions.
  • Manage timelines, resources, and budgets for projects, reporting progress to management.
Requirements
  • PhD, M.Sc, or B.Sc in analytical chemistry, polymer science, biochemistry, or biotechnology, coupled with relevant industry experience in Pharma/Biotech. Skilled in GMP analytical method development for biologic product quality control.
  • Proficient in various analytical instruments and familiar with regulatory compliance.
  • Strong analytical and communication skills, with proficiency in statistical software.
About Stratacuity

Stratacuity is a leading provider of scientific placement services, dedicated to building lasting relationships with exceptional biopharmaceutical talent. Our team is committed to protecting your personal information and ensuring a seamless recruitment process.

We are an Equal Employment Opportunity/Affirmative Action Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.