Senior Scientist - Extractables & Leachables
Boston Analytical is a premier cGMP compliant laboratory, FDA and DEA registered for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction, and to the fast and accurate analysis of our clients' products.
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
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.
Boston Analytical is a growing pharmaceutical contract lab providing quality Analytical Development, Microbiological, Stability, Extractables and Leachables Testing Services. We are known for our quality and believe our success is driven by our employees. We provide our employees with a state-of-the-art work environment, excellent benefits and opportunities for development.