Scientist, Research Scientist

Position: Scientist I
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 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.

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