What are the responsibilities and job description for the Senior Scientist, Analytical Development position at Alkermes?
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
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
