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.
Qualification 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.