Analytical Development Lead - Small Molecules

Alkermes; Massachusetts; On-site; USD 131,000 - 142,000; Full time

Job summary

Alkermes is seeking an Analytical Development Supervisor to provide technical and operational leadership for small molecule analytical activities within our Pharmaceutical Development organization. This role coordinates testing across manufacturing, ensuring high-quality data to support process development and manufacturing.

The successful candidate will bring strong scientific expertise, people leadership, and cross-functional collaboration in a GMP environment, driving timely project execution

Qualifications

• MS (>5 years) or BS (>10 years) with related experience in analytical chemistry or quality control.
• Strong understanding of the role of Analytical Development within the drug development process.
• Experience with advanced analytical techniques (HPLC/UHPLC, LC/MS, GC, Dissolution, FTIR, UV/Vis, KF, laser diffraction, etc.).
• Familiarity with operation and troubleshooting of LC instrumentation/software (Waters, Agilent, Gilson, etc).
• Experience in a GMP regulated analytical environment.
• Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Demonstrated supervisory or team leadership, coordination and team development capabilities.
• Ability to prioritize tasks and responsibilities for work assignments to meet project timeline.
• Excellent verbal and written communication skills.

Responsibilities

• Partner with Process Development, Manufacturing, Quality, Regulatory, and Project Management teams to support development programs
• Coordinate with manufacturing team to schedule analytical testing activities and sample prioritization
• Supervise day to day testing to ensure compliance with all applicable procedures and timely completion
• Review and approve analytical data, reports, and documentation
• Author, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms
• Review and approve electronic laboratory notebooks and data packages
• Oversee laboratory equipment, qualification, maintenance programs, and operational readiness
• Support laboratory safety initiatives and continuous improvement activities.
• Troubleshoot analytical methods and investigate technical issues to ensure timely project execution
• Technical oversight of GMP suite environmental monitoring testing and trending
• Perform other duties as assigned

Education

MS (>5 years) or BS (>10 years) in analytical chemistry or quality control

Job description

Alkermes is seeking an Analytical Development Supervisor to provide technical and operational leadership for small molecule analytical activities within our Pharmaceutical Development organization. This role coordinates testing across manufacturing, ensuring high-quality data to support process development and manufacturing.

The successful candidate will bring strong scientific expertise, people leadership, and cross-functional collaboration in a GMP environment, driving timely project execution