Dental Research Scientist

3 weeks ago

Waltham MA, United States Alkermes Full time

The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization. Provide subject matter expertise in analytical development methodologies at Alkermes requiring internal laboratory execution and technical oversight/supervision
Guide and drive analytical method development, method implementation, product characterization and analytical control strategy development for pre-clinical and clinical stage development programs
Design, execute, and analyze analytical method validation and transfer activities suitable for progressive stages of small molecule pharmaceutical development that are in compliance with ICH and FDA guidance
Work closely with colleagues across Pharmaceutical Development and Research organizations to best leverage internal and/or external capabilities, equipment and instrumentation to identify and document critical factors to impact method performance
Provide timely technical support and management oversight of analytical activities at external partners, which may include product characterization, GMP in process, release and stability testing, laboratory investigations, and method performance issues
Develop, review, and approve analytical source documents, and author and review drug product and drug substance analytical sections for regulatory submissions
Present technical data to cross functional teams and senior management as an analytical expert, and effectively communicate critical analytical issues and solutions
Train and mentor more junior Analytical Development staff, as needed
PhD (
~15 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
~ Experience managing external testing laboratories throughout drug development
~ Technical problem-solving ability utilizing current research and technologies
~ Subject matter proficiency across a range of spectroscopic, titration, dissolution and separation-based analytical methodologies and laboratory software systems
~ Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

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