Quality Control Manager (Cell Therapies)

TL;DR

Quality Control Manager (Cell Therapies): Overseeing analytical functions and laboratory operations for cell therapy programs with an accent on cGMP compliance, data integrity, and team leadership. Focus on managing release and stability testing, troubleshooting analytical methods, and representing the QC department in cross-functional investigations.

Location: Must be based in Boston or Cambridge, MA (On-site)

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Manage laboratory programs including assay readiness, sample management, and data reporting.
• Ensure all laboratory activities and records strictly adhere to cGMP and GDP expectations.
• Lead sub-teams in continuous improvement initiatives and provide guidance on OOS/OOT investigations.
• Coach and develop direct reports while ensuring appropriate training for lab personnel.
• Serve as the QC representative in cross-functional teams and coordinate with external vendors.
• Assist in troubleshooting analytical methods and equipment to maintain operational efficiency.

Requirements

• Bachelor's degree in a science-related discipline.
• 8+ years of experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of US and EU cGMP regulations and experience with regulatory inspections.
• Proficiency in analytical methodologies including flow cytometry, cell-based assays, qPCR, ELISA, and endotoxin testing.
• Ability to work five days per week on-site in Boston/Cambridge.
• Effective communication skills and ability to manage multiple project timelines.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Financial support including 401(k) matching and student loan repayment programs.
• Educational assistance and professional growth resources.
• Commuting subsidy and flexible work environment.