GMP Technical Writer

Emd Group; St. Louis (MO); On-site; USD 76,000 - 114,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Strong composition skills

Attention to detail

Excellent written communication

Cross-functional communication

GMP equipment knowledge

Education

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

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

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 candidatewith strong composition skills and comprehensive technical knowledge and understanding ofmanufacturing equipment and production processes

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in Biology, Chemistry, Biochemistry or other Life Science discipline
• 2 + years’ experience in GMP Operations, manufacturing, or production operations

Preferred Qualifications:

• 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
• Strong composition skills – Able to convey technical, safety, and GMP compliance informationand instruction through writing
• Comprehensive technical knowledge and understanding of GMP manufacturing equipment andproduction processes
• Effective communication with internal departments and customers

RSREMD

Pay Range for this position: $75,700.00 - $113,500.00

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!