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Senior Analytical Development Scientist
2 months ago
We are seeking a highly skilled and experienced Senior Analytical Development Scientist to join our team at Alkermes. As a key member of our Pharmaceutical Development organization, you will provide technical leadership and expertise in analytical development methodologies, driving the successful development of new drugs.
Key Responsibilities- Provide subject matter expertise in analytical development methodologies, including method development, validation, and transfer, to support pre-clinical and clinical stage development programs.
- Design, execute, and analyze analytical method validation and transfer activities, ensuring compliance with ICH and FDA guidelines.
- Collaborate with colleagues across Pharmaceutical Development and Research organizations to leverage internal and external capabilities, equipment, and instrumentation to drive method performance.
- Provide technical support and management oversight of analytical activities at external partners, including product characterization, GMP in-process, release, and stability testing.
- 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, effectively communicating critical analytical issues and solutions.
- 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 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 and independently manage priorities and maintain timelines for multiple activities.
