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Senior Analytical Development Scientist

2 months ago


Cambridge, Massachusetts, United States Apex Systems Full time
Job Summary

We are seeking a highly skilled Senior Analytical Development Scientist to join our team at Apex Systems. As a key member of our analytical development team, you will be responsible for guiding pharmaceutical advancements from inception through clinical stages and collaborating with internal and external partners.

Key Responsibilities
  • Method Development: Develop specialized testing methodologies for small molecule drugs using HPLC and GC.
  • Impurity Characterization: Oversee impurity characterization and stability studies for drug substances and products, ensuring regulatory compliance.
  • Project Management: Manage analytical testing and development activities with external partners to keep projects on schedule.
  • Collaboration: Collaborate on CMC, quality processes and regulatory submissions, providing internal and external project alignment.
Requirements
  • Education: PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product.
  • Expertise: Expertise in method development for small-molecule drugs, with broad analytical expertise including HPLC, GC, MS, and NMR techniques.
  • Regulatory Knowledge: Knowledgeable in GMP/ ICH guidelines and adept at managing stability studies.
  • Leadership: Skilled in guiding CDMOs, drafting regulatory documents, and leading cross-functional project teams.
About Apex Systems

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.