Supervisor, Analytical Development

Scorpion Therapeutics; United States; On-site; USD 131,000 - 142,000; Full time

Benefits offered by this job

Competitive benefits package

Annual performance pay bonus

Job summary

Scorpion Therapeutics seeks an experienced analytical chemist with GMP expertise to lead analytical development activities in a fast-paced environment. You will supervise testing, review data, and ensure compliance across QC workflows.

The role requires strong LC/LC-MS, HPLC/UHPLC skills and a track record of coordinating cross-functional teams to meet project timelines.

Qualifications

• MS or BS in analytical chemistry or quality control with relevant experience
• GMP regulated analytical environment experience preferred
• Understanding of ICH, FDA, USP guidelines in drug development
• Demonstrated supervisory and coordination skills

Responsibilities

• Partner with PD, Manufacturing, QA, Regulatory, and PM to support development programs
• Coordinate with manufacturing to schedule analytical testing and sample prioritization
• Supervise day-to-day testing for compliance and timely completion
• Review and approve analytical data, reports, and documentation
• Author, revise, or review SOPs, analytical protocols, reports, specifications, and forms
• Review and approve electronic lab notebooks and data packages
• Oversee lab equipment, qualification, maintenance, and readiness
• Support safety initiatives and continuous improvement activities
• Troubleshoot analytical methods and investigate issues
• Provide technical oversight of GMP environmental monitoring and trending
• Perform other duties as assigned

Skills

Analytical chemistry

Quality control

GMP knowledge

Team leadership

Education

MS in analytical chemistry

BS in analytical chemistry

Tools

LC/LC-MS

HPLC/UHPLC

Spectroscopy

Job description

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