GMP Technical Writer

About the position

The Technical Writer is responsible for the creation of batch records for use in GMP manufacturing of new and existing custom bioconjugation products. This technically sound position works crossfunctionally at multiple manufacturing facilities with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop robust manufacturing batch records from Tech Transfer documents. We're looking for a candidate with strong composition skills and comprehensive technical knowledge and understanding of manufacturing equipment and production processes. The position will be based in at our Cherokee site in St. Louis, Missouri.

Responsibilities

• Authorship of new product MMFs and associated technical documents
• Manage MMF priorities based on schedule and project requirements
• Participate in process design flow efforts
• Provide logical explanations and potential solutions for roadblocks to GMP
• Collaborate with other departments and external customers
• Interface with management, other departments and customers to collaborate, identify, and implement tech transfer activities
• Write and modify procedures consistent with quality guidelines and review other procedures as requested
• Participate and assist deviation investigations from Technical Operations perspective
• Identify and mitigate safety hazards with transferred manufacturing processes

Requirements

• Bachelor's Degree in Biology, Chemistry, Biochemistry or other life science discipline
• 1 + years' experience in GMP Operations, manufacturing or production operations

Nice-to-haves

• Excellent attention to detail in written instruction and communication
• Strong composition skills
• Ability to convey technical, safety, and GMP compliance information and instruction through writing
• Comprehensive technical knowledge and understanding of GMP manufacturing equipment and production processes
• Ability to effectively communicate with internal departments and customers