Sr. Scientist/Associate Principal Scientist
Alkermes
- Waltham, MA
- Permanent
- Full-time
- 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
- PhD (
7 years) with related experience in analytical chemistry, organic chemistry, or biochemistry * 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