Job Description
Job DescriptionSalary:
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.
PRIMARY DUTIES AND RESPONSIBILITIES
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.
REQUIREMENTS & QUALIFICATIONS
Qualification includes a Ph.D. in Analytical Chemistry with 2+ years experience or a Masters
degree and 4+ years experience or a Bachelors 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.
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 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