Senior Scientist, Analytical Development
Alkermes
July 01, 2026
On-site
Greater Boston
Operations
Responsibilities:
- Lead analytical method development, method implementation, product characterization, and analytical control strategy development for pre-clinical and clinical stage programs.
- Provide technical support and daily management of outsourced drug substance/drug product analytical activities (in-process, release, and stability testing) with external partners.
- Design and support analytical method transfer and validation for a portfolio of small molecule, solid oral dosage projects.
- Lead laboratory investigations to determine root cause and implement corrective actions.
- Collaborate with CMC functions/leadership to develop analytical strategies and deliver objectives.
- Author and review drug substance and drug product analytical sections for regulatory submissions.
- Present and communicate critical analytical issues and solutions to cross-functional teams.
- Stay current with emerging technologies and industry trends to support Analytical Development.
- Perform other duties as assigned.
Qualifications:
- PhD (>3 years) or MS (>7 years) in analytical chemistry, organic chemistry, or biochemistry.
Preferred Qualifications/Skills:
- Expertise in analytical method development (separation/spectroscopic techniques), including discriminating dissolution test methods.
- Experience with mechanistic investigations, stability-indicating method development, rapid shelf-life determinations (ASAP prime), cGMP stability studies, and stability problem-solving.
- Experience in a GMP regulated analytical environment.
- Understanding of Analytical Development’s role; strong leadership/interpersonal skills and excellent written/verbal communication.
- Ability to apply ICH/FDA/USP guidelines in context.
- Proven ability to work in fast-paced team/matrix environments and manage priorities/timelines.
Compensation/Benefits:
- Annual base salary: $151,286–$161,030; eligible for an annual performance pay bonus; competitive benefits package.
Application Instructions:
- Additional details: www.alkermes.com/careers#working-here
- Lead analytical method development, method implementation, product characterization, and analytical control strategy development for pre-clinical and clinical stage programs.
- Provide technical support and daily management of outsourced drug substance/drug product analytical activities (in-process, release, and stability testing) with external partners.
- Design and support analytical method transfer and validation for a portfolio of small molecule, solid oral dosage projects.
- Lead laboratory investigations to determine root cause and implement corrective actions.
- Collaborate with CMC functions/leadership to develop analytical strategies and deliver objectives.
- Author and review drug substance and drug product analytical sections for regulatory submissions.
- Present and communicate critical analytical issues and solutions to cross-functional teams.
- Stay current with emerging technologies and industry trends to support Analytical Development.
- Perform other duties as assigned.
Qualifications:
- PhD (>3 years) or MS (>7 years) in analytical chemistry, organic chemistry, or biochemistry.
Preferred Qualifications/Skills:
- Expertise in analytical method development (separation/spectroscopic techniques), including discriminating dissolution test methods.
- Experience with mechanistic investigations, stability-indicating method development, rapid shelf-life determinations (ASAP prime), cGMP stability studies, and stability problem-solving.
- Experience in a GMP regulated analytical environment.
- Understanding of Analytical Development’s role; strong leadership/interpersonal skills and excellent written/verbal communication.
- Ability to apply ICH/FDA/USP guidelines in context.
- Proven ability to work in fast-paced team/matrix environments and manage priorities/timelines.
Compensation/Benefits:
- Annual base salary: $151,286–$161,030; eligible for an annual performance pay bonus; competitive benefits package.
Application Instructions:
- Additional details: www.alkermes.com/careers#working-here