Supervisor, Analytical Development

Responsibilities:
- Partner with Process Development, Manufacturing, Quality, Regulatory, and Project Management teams to support development programs
- Coordinate with manufacturing to schedule analytical testing activities and sample prioritization
- Supervise day-to-day testing to ensure compliance and timely completion
- Review and approve analytical data, reports, and documentation
- Author, revise, or review SOPs, 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
- Provide technical oversight of GMP suite environmental monitoring testing and trending
- Perform other duties as assigned

Qualifications:
Basic:
- MS (>5 years) or BS (>10 years) in analytical chemistry or quality control

Preferred:
- Understanding of Analytical Development in the drug development process
- Experience with advanced analytical techniques (HPLC/UHPLC, LC/MS, GC, dissolution, FTIR, UV/Vis, KF, laser diffraction, etc.)
- Strong LC instrumental background; familiarity with LC instrumentation/software operation and troubleshooting (e.g., Waters, Agilent, Gilson)
- Experience in a GMP regulated analytical environment
- Knowledge of ICH, FDA, and USP guidelines applicable to drug development stage
- Demonstrated supervisory/team leadership and coordination
- Ability to prioritize to meet project timelines
- Excellent verbal and written communication skills

Compensation/Benefits:
- Annual base salary range: $131,000–$142,000
- Eligible for annual performance pay bonus
- Competitive benefits package
- Details: www.alkermes.com/careers#working-here