Boston Analytical
Job Description
Job Description Salary: 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
Job Description Salary: 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