Associate Principal Scientist Analytical Project Lead 12 months fix-term contract 80-100%
Core
Lead analytical project delivery and strategy for drug product development, ensuring method lifecycle management and regulatory compliance for biotechnology products.
Role type
Associate Principal Scientist Analytical Project Lead
Builds
Analytical methods, control strategies, and regulatory filings for parenteral dosage forms and protein analytics
Domain
Life Sciences / Pharmaceutical Manufacturing / Analytical Chemistry
Required skills
Analytical method development and evaluation, cGMP compliance, HPLC and CE purity methods, UV content analysis, pH and osmolality testing, extractable volume assessment, visual inspection, CCI testing, parenteral dosage form expertise, protein analytics, analytical lifecycle management, CMC regulatory filing knowledge, matrix organization navigation
Preferred skills
Experience with biotechnology products, formulation development support, Drug Product testing (via careerplan.io/jobs/R79242-associate-principal-scientist-analytical-project-lead-12-months-fix-term-contract-80-100-a)
Technologies
HPLC, CE, UV, pH meters, osmolality meters, CCI equipment
Responsibilities
Lead analytical discussions with customers and interface with Subject Matter Experts, ensure project timelines and deliverables are tracked, oversee delivery of analytical milestones, support Project Leads with analytical Statements of Work, set up strategy for analytical programs including control strategy and method lifecycle, maintain knowledge of assigned molecules and industry trends, manage development of analytical methods for formulation and testing, contribute to design of analytical development processes
Seniority
Senior, hands-on IC