Validation / Calibration

Process Validation Leader, Biologics Direct Hire MA

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Job ID: 14752 Direct Hire MA

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Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking an experienced Validation professional to head up the Process Validation function and manage the relationship with external CMO partners.  You will provide expertise to technical teams in the implementation of strategies for characterization and process validation studies.  

The main function of this role is to provide expertise to CMC and Technology Transfer teams in the implementation of strategies for characterization and process validation studies.  

Responsibilities include but are not limited to;
•  Participate in risk assessments that identify potential critical process parameters and key operating parameters for all the unit operations in the process.
•  Prioritize process characterization studies and the development of a control strategy in the larger context of the Quality by Design (QbD)
•  Author validation master plans comprising but not limited to process design plans, process validation plans, continued process verification plans and associated protocols and reports. 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in an Engineering, Life Science or related field and 7-10+ years of biopharmaceutical production experience including extensive knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process validation.  Must also have experience with Design of Experiments (DOE) approach for process development and characterization and prior experience with QbD initiatives and experience writing CMC documents and implementing QbD principles, tools, and processes.  

Must be authorized to work in the US indefinitely to be considered.  The internal groups this supports will be based in Cambridge.  Can hire those commutable to the Cambridge area or remote-based employees.  The amount of travel expected for this role is approximately 20-25%.     

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.