Principal Scientist, Formulation Development

Job Description Join the Alkermes Formulation Development team as a Principal Scientist, where you will lead the development of innovative small molecule pharmaceutical dosage forms. You will provide strategic and technical direction for drug product development and play a major role in the CMC and development teams. You will design and execute experiments with a focus on product understanding and robustness, interpret data, and write technical and regulatory documents. Responsibilities

• Provide technical leadership in designing and executing lab-based experiments to develop small molecule immediate or modified release formulations across various stages, from concept to commercialization.
• Give strategic planning to meet project deliverables within timelines, incorporating both immediate and long-term goals.
• Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities.
• Collaborate within cross-functional teams to execute development strategies that enable successful launch of Alkermes products. This includes internal clinical and commercial manufacturing teams, as well as CDMOs.
• Author necessary documentation, including regulatory submissions.
• Maintain and enhance scientific / technical knowledge, champion ideas for new projects, and mentor junior scientists. Qualifications
• Proven track record of leading the development of small molecule formulations through the clinic into commercial.
• Deep and thorough understanding of the development of pharmaceutical dosage forms with a focus on how physicochemical properties impact dosage form development and product quality.
• Proficiency in development / lab-scale production equipment such as tableting, granulation, blending, milling, spray drying, coating, drying.
• Proven ability to apply scientific principles to design, execute, and interpret experiments.
• Excellent communication, organization, and planning skills.
• Solid knowledge of cGMPs and applicable regulatory guidance.
• Ability to interact and collaborate within a diverse and interdisciplinary team environment on creative problem-solving, fostering diversity, inclusion, and belonging.
• Proficiency in statistical design of experiments.
• Degree in chemical engineering, pharmaceutical science, materials science, or related physical science with a PhD and 8 years, or an MS with 15 years, or a BS with 20 years of experience in pharmaceutical development.
• Experience with modified release formulations is preferred. #LI-MB1 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.

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