EMPLOYMENT

EMPLOYMENT

Senior Scientist – Extractables & Leachables

The Senior 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 non-volatile organic Extractables & Leachables samples.  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 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 reports 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 include 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 required. 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
  • Experience performing Extractables & Leachables studies on drug product packaging and/or manufacturing materials
  • Demonstrated LC-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.