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.
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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