Senior Bioprocess Scientist

Position: Process Validation/Regulatory Scientist 

Location: Worcester, MA – 100% Remote  

Job Description: 

As a Process Validation/Regulatory Scientist with cell culture process validation and monoclonal antibodies experience, you have the opportunity to join a renowned global pharmaceutical company in Worcester, MA. The ideal candidate is expected to be the primary author of biologics process validation protocols and reports. You will be responsible for designing process validation strategies to enable successful approval and launch of new biologics.  

Process Validation/Regulatory Scientist Minimum Qualifications: 

• B.S. or M.S. degree in a Scientific or Engineering discipline  
• 5+ years of experience supporting biologics manufacturing process development in process validation 
• Understanding of operations in cell culture and/or protein purification 
• Experience working with monoclonal antibodies 
• Experience filling out Process Performance Qualifications (PPQ) documents  
• Proficiency writing Biologics Licensing Applications (BLA) chapters within the IND application  

Responsibilities: 

• Validate existing biologics protocols, collect process validation data, and analyze results to create validation reports 
• Write validation PPQs 
• Be primary technical point of contact within manufacturing, developing process validation strategies.  

What’s In It For You: 

• The opportunity to join a global, renowned Pharmaceutical company