Vacancy expired!
Boston Analytical is a premier cGMP compliant, FDA and DEA registered, ISO/IEC-17025:2005 certified, pharmaceutical analytical testing laboratory. 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 satisfactionand to the fast and accurate analysis of our clients' products.Boston Analytical is a growing pharmaceutical contract lab providingquality Analytical Development, Microbiological, Stability,Extractables and LeachablesTesting 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.The Senior Scientist is responsible for leading and performing thedevelopment of analytical methods and attendant procedures, as well as validation of the developed analytical methods. This would also include developing study plans and writing validation protocols and reports. Techniques will include analysis of pharmaceutical products usingHPLC, GC, Dissolution, AA, UV-Vis, X-Ray, Thermal Analysis, and wet chemical analysis. Primary Duties and Responsibilities:
Develops methods based on client requirements.
Conducts research on manufactured products to develop, improve and validate test procedures.
Validates methods compliant with regulatory requirements.
Generates protocols and reports for method development, validation, and transfer.
Conducts independent assessment of method performance and address issues.
Devises and develops processes and methods for the solution of technical problems.
Confers with chemists and client personnel regarding research, procedures performed, related results, and prepares technical papers, protocols and reports.
Follows all safety rules and regulations and conducts periodic safety audits.
Ensuresall appropriate work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration and United States Pharmacopeia or othercompendialmethodologies.
Supervises, trains, and mentors other chemists on an as needed basis.
Provides planning and oversite on projects, establishing the approach, required resources, timing and meeting agreed timelines.
Performs work at a level considered subject matter expert. As subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve procedures and/or training programs.
Performs advanced data generation, analysis and complicated problem solving independently with minimal rework.
Reviews and assesses discrepancies; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
This position requires an advanced degree - a PhD, Master’s or Bachelor’s degree in Chemistry or a related discipline. Must have laboratory experience with a minimum of 2+ years of experience related to small molecule drug development, combined with a Master’s degree as described above; or a minimum of 5+ years of related work experience combined with a Bachelor’s degree as described above. Experience with analytical method development, particularly in chromatographic methods. Knowledge of cGMPs and related compliance regulations and guidances required, especially around requirements for analytical method development and validation.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 documentation skills.
Solid writing ability and computer skills.
Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
Must be a team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.
(474076121)
Vacancy expired!