MS&T Scientist

Responsibilities

• Provide technical support for upstream and/or downstream manufacturing operations
• Analyze process data to identify trends, deviations, and opportunities for improvement.
• Lead investigations into process deviations and implement CAPAs
• Support or lead technology transfer activities from development to clinical or commercial manufacturing sites.
• Participate in process scale-up studies and validation campaigns.
• Collaborate with cross-functional teams to ensure successful execution of process performance qualification (PPQ) and continued process verification (CPV)
• Prepare technical reports, presentations, and documentation for internal and regulatory use

Qualifications

• 4+ years of experience working in upstream or downstream manufacturing operations
• Experience working in a GMP (Good Manufacturing Environment)
• MS&T experience highly desired for this role
• Strong understanding of biologics manufacturing processes including mammalian cell culture, purification, formulation scale up processes
• Experience with monoclonal antibodies and cell/gene therapies preferred
• Tech transfer across manufacturing sites would be ideal experience for candidate
• Bachelor’s degree in life science related field

Compensation

Salary: Between $80,000 - $115,000 based on years of relevant experience

Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO (Paid Time Off), Paid Holidays, Sick Leave as required by law