Principal Scientist

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. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.

• 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
• Identify and advocate new and emerging technology opportunities for analytical and physical characterization
• Train and mentor more junior Analytical Development staff, as needed
• Perform other duties as assigned

• PhD (>8 years) or MS (>15 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
• Expertise and demonstrated experience in small molecule analytical method development, validation and transfer
• Experience managing external testing laboratories throughout drug development
• Technical problem-solving ability utilizing current research and technologies
• Broad understanding of the drug development process and more precisely the role and impact of analytical development within this process
• Demonstrated collaborative leadership, strong interpersonal skills, and excellent verbal and written communication skills
• Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
• Subject matter proficiency across a range of spectroscopic, titration, dissolution and separation-based analytical methodologies and laboratory software systems
• Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities
• Previous experience with applying DoE in method development is preferred

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Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes 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 various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.