Scientist II

In this role you will perform complex chemical and physical testing of pharmaceutical materials and final products, developing and transferring test methods and ensuring regulatory compliance. You will work within Analytical R&D to support method validation, troubleshooting, and data reporting, collaborating with clients and other departments. The position offers impact in method development, quality control, and regulatory documentation. This is a hands-on, precision-focused role in a fast-paced pharma environment.

• Conduct complex chemical and physical testing of raw materials, packaging components, finished products, microbiological and stability samples using internal and compendial methods
• Develop and transfer/verify/validate test methods (strength, impurities, identity, dissolution) using HPLC, GC, dissolution, KF, spectroscopy and wet chemistry
• Identify out-of-spec results and non-routine analytical issues, and propose solutions
• Maintain and troubleshoot analytical instrumentation
• Document results clearly and accurately; generate reports and communicate findings; may interact with clients
• Prepare and assist with regulatory filings for internal projects and coordinate with external departments, sites, agencies, and clients
• Write SOPs and instructional documents
• Keep work area, instruments, and materials organized and compliant with lab procedures
• Maintain compliance with company and facility standards

• BS with 2+ years of pharmaceutical industry experience or advanced degree
• Experience with potent/cytotoxic materials and parenteral products preferred
• Proficiency with analytical instruments and methods (HPLC, GC, KF, dissolution)
• Knowledge of GMPs and pharmaceutical regulatory requirements
• Strong problem-solving abilities and data interpretation skills
• Good written and verbal communication skills
• Ability to respond to inquiries from customers or regulatory agencies
• Ability to apply mathematical operations for test reliability and statistics

• strong communication (oral and written)
• ability to work in cross-functional teams
• detail-oriented
• HPLC
• GC
• KF