Supervisor, Analytical Development

Alkermes

8d•Onsite

About The Position

The Analytical Development Supervisor provides technical and operational leadership for small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. This role coordinates manufacturing area testing activities, ensuring the delivery of high-quality analytical data to support process development and manufacturing. The position requires strong scientific expertise, people leadership, and cross-functional collaboration in a regulated environment. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.

Requirements

MS (>5 years) or BS (>10 years) with related experience in analytical chemistry or quality control
Good 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.)
Strong instrumental background, 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