Senior Scientist – Extractables & Leachables

The Senior Scientist will contribute to Extractables & Leachables studies performed at Boston Analytical to support client submissions.  The ideal candidate would have experience operating LC-MS systems and interpreting LC-MS data to identify extractables and leachables compounds.  The senior scientist role is also expected to serve as study director for E&L studies, including drafting protocols and assembling data into final reports.

PRIMARY DUTIES AND RESPONISIBITIES

• Prepares samples for analysis by LC-MS.
• Analysis of sample solutions by LC-MS to adequately resolve and identify all compounds.
• Interpretation of Mass Spectral data to identify extractables and leachables compounds.
• Coordinate LC-MS findings with sample data from GC-MS and ICP-MS analyses.
• Author detailed cGMP reports outlining study findings.
• Develop LC-MS methods for drug product stability 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.

Requirements:

Qualification include a Ph.D. in Analytical Chemistry with 4+ years’ experience performing and interpreting LC-MS analysis or Master’s degree and 8+ years’ experience. Knowledge of cGMPs and current E&L best practices required.

Minimum Skills Requirements:

• 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 operation and data interpretation capability.
• Ability to develop and optimize HPLC and UPLC methods.

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