GMP Technical Writer: Biologics Batch Records

Emd Group; St. Louis (MO); Presencial; USD 76.000 - 114.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Descripción de la vacante

MilliporeSigma is seeking a GMP Technical Writer in St. Louis, MO to create batch records for GMP manufacturing of a new biologic drug substance.

You will work with Manufacturing, Process & Analytical Development, Quality, and Project Management to develop robust Tech Transfer documents, ensuring accuracy and compliance. The role requires strong composition and writing skills, with deep knowledge of GMP equipment and processes, and the ability to communicate effectively with internal teams and

Formación

• Bachelor’s degree in Biology, Chemistry, Biochemistry or Life Science.
• 2+ years’ GMP Operations, manufacturing, or production operations experience.
• 5+ years’ GMP Operations, manufacturing, or production operations (preferred).
• 3+ years writing technical documentation to support GMP operations.
• Excellent attention to detail in written instruction and communication.
• Strong composition skills to convey technical GMP information in writing.
• Comprehensive knowledge of GMP manufacturing equipment and production processes.
• Effective cross-departmental and customer communication.

Responsabilidades

• Create batch records for GMP manufacturing of the new biologic drug substance.
• Collaborate with Manufacturing, Process & Analytical Development, Quality, Project Management, and customers to develop batch records.
• Translate complex processes into clear, compliant manufacturing documents.

Conocimientos

Strong composition skills

Attention to detail

Excellent written communication

Cross-functional communication

GMP equipment knowledge

Educación

Bachelor’s degree in Biology, Chemistry, Biochemistry or Life Science

Descripción del empleo

MilliporeSigma is seeking a GMP Technical Writer in St. Louis, MO to create batch records for GMP manufacturing of a new biologic drug substance.

You will work with Manufacturing, Process & Analytical Development, Quality, and Project Management to develop robust Tech Transfer documents, ensuring accuracy and compliance. The role requires strong composition and writing skills, with deep knowledge of GMP equipment and processes, and the ability to communicate effectively with internal teams and