Senior Scientist/Associate Principal Scientist, Analytical Development

Job Description

General Description:

The Senior Scientist/Associate Principal Scientist position within the Analytical Development will lead small molecule analytical activities in a matrix environment. The successful candidate will work with a cross-site analytical development team to characterize a variety of molecules including drug substance, drug product, impurities, degradants, and metabolite from discovery through clinical development, to commercialization. The role also provides laboratory support via reference standard management, GxP expertise to the ongoing projects, including the GMP stability chamber management. He/she will thrive in a highly collaborative matrix team environment to enable critical decision-making and ensure the successful development of new drugs.

Key Duties:

• Provide subject matter expertise in chromatography analytical development activities at Alkermes requiring internal laboratory execution and oversight/technical supervision of contractors
• Guide and drive analytical method development, implementation as well as drug substance and drug product characterization and control for pre-clinical and early clinical stage development programs
• Perform reference standard management
• Understand chemical and formulation development to identify and document critical factors that impact method performance and/or analytical development activities
• Design validation protocols that are in compliance with ICH and FDA guidelines, identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
• Manage all aspects of the GMP stability storage operations and ensuring compliance with internal procedures, industry regulations, and regulatory guidelines
• Serve as the direct technical contact with contract manufacturing and testing labs
• Lead a matrix cross-site AD team to develop methods, qualify/validate the methods, and test samples
• Timely monitor and evaluate GMP release and stability data from CMOs and CROs, potential out of specification, out of trend, and method performance issues and supervise or conduct investigations and implement corrective actions as needed
• Develop, review, and approve source documents for regulatory submissions
• Present to cross functional teams and effectively communicate critical analytical issues and solutions
• Identify technology opportunities and fill the technical gaps within AD Waltham
• Perform other duties as assigned

Skills/Abilities:

• Expertise and experiences in liquid chromatography and GC method development and validation is required
• Demonstrated success in a GMP regulated analytical environment
• Good understanding of experimentation and data analysis using Empower software
• Broad understanding of the drug development process, including discovery lead optimization, preclinical/clinical design, regulatory filings, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential
• Demonstrated leadership skills and excellent verbal and written communication skills are essential
• Good understanding of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
• Excellent interpersonal and team skills are required
• The ability to work successfully in both a team/matrix environment as well as independently is required
• The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple activities are required

Personal Attributes:

• Self-Motivated
• Team player
• Committed to quality
• Well organized and efficient
• Good interpersonal and communication skills
• Good problem solver
• Critical, analytical thinker
• Manages multiple duties and projects
• Easily adaptable to change
• Brings closure to work in a timely manner

Education And Experience:

• Doctoral (>3 years) or master's (>7 years) degree of related experience in analytical chemistry, organic chemistry, or biochemistry
• Experience in leading multiple activities and interacting with multiple functional areas is desired

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About Us

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D 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.