Position Summary:

The Senior Scientist position within Analytical Development leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They will collaborate with cross-functional teams on analytical method development, molecule characterization, testing and analysis throughout various stages of drug development. They will perform internal laboratory work as well as manage external partners for method development, validation, and analytical testing, including stability program design and execution. The successful candidate will thrive in a highly collaborative matrix team environment to ensure the successful development of new drugs.

Responsibilities:

• Lead analytical method development, method implementation, product characterization and analytical control strategy development for pre-clinical and clinical stage development programs
• Provide timely technical support and daily management of outsourced drug substance and drug product analytical activities with external partners, including in-process, release and stability testing 
• Design and support analytical method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects. 
• Lead laboratory investigations to determine root cause and implement corrective actions as needed
• Collaborate with various CMC functions and CMC leadership to develop analytical strategies and deliver on key objectives
• Author and review drug substance and drug product analytical sections for regulatory submissions
• Present to cross functional teams and effectively communicate critical analytical issues and solutions
• Stay current with emerging technologies and industry trends to support Analytical Development
• Perform other duties as assigned

Preferred Requirements: 

• PhD (>3 years) or MS (>7 years) with related experience in analytical chemistry, organic chemistry, or biochemistry

Basic Requirements: 

• Subject matter expertise in analytical method development for various separation and spectroscopic techniques with particular hands-on experience in developing discriminating dissolution test methods 
• Experienced in mechanistic and scientific investigations, stability-indicating method development, rapid shelf-life determinations based on ASAP prime software, cGMP stability studies, and creative stability problem solving
• Experience in a GMP regulated analytical environment preferred
• Good understanding of the role of Analytical Development within the drug development process
• Solid leadership skills and interpersonal skills and excellent verbal and written communication skills
• Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
• Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain project timelines

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About Us

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.