Scientist, Research Scientist, Clinical Research

Overview

JOB SUMMARY
The Scientist will contribute to Extractables & Leachables studies performed in the E&L laboratory at Boston Analytical to support client submissions. The ideal candidate will have experience operating LC-MS and GC-MS systems for analysis of volatile, semi-volatile, and nonvolatile organic extractables and leachables samples.

• Prepares extractions for analysis.
• Analysis of sample extract solutions by GC-MS and LC-MS to adequately resolve and identify all compounds.
• Coordinate findings with the team to generate conclusions.
• Author detailed cGMP report sections for work performed outlining study findings.
• Develop analysis methods for drug product leachables testing.
• Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Ensures all work performed strictly adheres to Company, client and Pharmacopial requirements.
• Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

Qualification includes a Ph.D. in Analytical Chemistry with 2+ years’ experience or a Master’s degree and 4+ years’ experience or a Bachelor’s with 6+ years’ of experience performing and interpreting MS analysis. Knowledge of current Extractable & Leachables guidance (USP, ISO 10993) and best practices preferred. Experience working in a cGMP environment required.

• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, verbal communication and technical writing skills.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.
• Demonstrated LC-MS and/or GC-MS operation and data interpretation capability.
• Ability to develop and optimize HPLC, UPLC, and GC methods.
• Documented success managing complex projects to completion within customer expectations for deadline, cost, and overall deliverable.