GMP Technical Writer
The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO
•$75,700 - $113,500•Onsite
About The Position
The GMP Technical Writer at the St. Louis, MO site is responsible for the creation of batch records for use in GMP manufacturing of the new custom biologic drug substance. This role works functionally with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop robust manufacturing batch records for 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.
Requirements
- Bachelor’s degree in Biology, Chemistry, Biochemistry or other Life Science discipline
- 2 + years’ experience in GMP Operations, manufacturing, or production operations
- Strong composition skills – Able to convey technical, safety, and GMP compliance information and instruction through writing
- Comprehensive technical knowledge and understanding of GMP manufacturing equipment and production processes
- Effective communication with internal departments and customers
Nice To Haves
- 5 + years’ experience in GMP Operations, manufacturing, or production operations
- 3+ years writing technical documentation to support GMP operations
- Excellent attention to detail in written instruction and communication
Responsibilities
- Creation of batch records for use in GMP manufacturing of the new custom biologic drug substance.
- Works functionally with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop robust manufacturing batch records for Tech Transfer documents.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
