Manufacturing Sciences and Technology (MSAT) Specialist - Upstream Sciences

Summary: Provide technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generate facility fit assessments and high level gap assessments.
• Generate and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate).
• Generate options to resolve technical challenges and present them for endorsement.
• As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the sites.
• Gather, trend, and analyze process generated data; summarize findings in memos and reports and presentations.
• Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.).
• Participate in study teams and investigations (internal and external).
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Monitor and prioritize processes and troubleshoot technical difficulties as needed.
• Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
• Help to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identify continuous improvement activities to improve performance.
• Travel may be required in support of tech transfer activities.
• May involve supervision of lower level specialists.

Education and Experience:

• Title level (Manufacturing Sciences and Technology Specialist, Manufacturing Sciences and Technology Specialist, or Senior Manufacturing Sciences and Technology Specialist) will be determined based on skills and experience.
  
   

To be considered for this role you must hold a Bachelor’s degree in Engineering, Life Sciences or a related field and the following minimum amounts of relevant experience for each level:

• Assoc Specialist–BS/BA or MS
• Specialist–BS/BA + 2 – 5 years of experience or MS + 1 – 4 years of experience
• Senior Specialist –BS/BA +5 – 8 years of experience or MS + 4 – 7 years of experience