Job DescriptionThe 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.
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
QualificationsBasic Qualifications: - MS (>5 years) or BS (>10 years) with related experience in analytical chemistry or quality control
Preferred Qualifications:- 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
The annual base salary for this position ranges from $131,000 to $142,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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