Manager, Quality Control and Analytical Development

📋 Description

• Plan, coordinate and manage routine release testing and applicable stability programs at external
• Manage the technology transfer of method development, qualification and validation activities to
• Conduct technical review and trend analysis of in process, release and stability data across API
• Drive analytical investigations of OOS, deviations, change controls, CAPAs, temperature excursions
• Support QC GMP systems by maintaining reference standard, critical reagent and method performance
• Author, review and approve documentation including technical reports, SOPs, test methods

🎯 Requirements

• BA/BS, MS or PhD in chemistry, biochemistry or related discipline
• 5+ years in biotech/pharmaceutical industry with at least 3 years in Quality Control/Analytical
• Technical knowledge of analytical methods for peptides and/or oligonucleotide products including
• Ability to analyze, trend, interpret, organize and present data; JMP or other statistical software
• Experience managing external GMP QC/AD teams at manufacturing and testing partners preferred
• Background in sterile drug product and environmental monitoring investigations is a plus

🎁 Benefits

• Remote work opportunities within the United States (except Alaska, Arizona, Hawaii, Michigan
• Travel to corporate location in Cambridge, MA and company events
• Pay range: $125,000-$141,000 USD
• Equal Opportunity Employer
• Accommodations available for candidates