Principal Scientist

Position Summary :

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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