Job Description
Job Description
Position Summary
The Scientist position within Analytical Development performs small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They develop new methods using chromatographic, characterization, and wet chemistry techniques to enable small molecule drug substance and drug product development throughout various stages of drug development. They will primarily perform internal laboratory work and interact with external partners for method development, validation, and analytical testing. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.
Responsibilities
- Develop, validate, and transfer methods for analysis of drug substance and drug product
- Perform independent hands-on experimental work using various chromatographic and spectroscopic techniques, KF, dissolution and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA
- Perform data analysis and interpretation
- Generate technical documents (eg, reports, lab notebooks, procedures) and technical presentations
- Present data to key stakeholders and management
- Troubleshoot technical problems for molecules in Discovery Research and drug development
- Evaluate new technologies for Alkermes
- Perform peer review of colleague's electronic notebooks
- Perform other duties as assigned
Qualifications
- PhD (0-3 years) or MS (>5 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
- Experience with advanced analytical techniques (HPLC/UHPLC, LC/MS, GC, Dissolution, FTIR, UV/Vis, KF, X-ray powder diffraction, DSC, TGA, etc.)
- Strong instrumental background, familiarity with operation and troubleshooting of LC instrumentation/software (Waters, Agilent, Gilson, etc)
- Knowledge of pharmaceutical sciences
- Familiarity with statistical analysis for analytical chemistry, including experimental design (DoE)
- Understanding of cGMPs, ICH guidelines, and compendial requirements
- Good oral and written communications
- Ability to prioritize tasks and responsibilities for work assignments to meet project timelines
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About Us
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 www.alkermes.com.
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. Alkermes is an E-Verify employer.
Date Posted
03/04/2024
Views
6
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