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Operations Technical Writer

2 months ago

Spring, United States Cellipont Bioservices Full time
Job DescriptionJob Description

Job Summary

Cellipont Bioservices is growing, and we are looking for an Operations Technical Writer (TEMP) who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The Operations Technical Writer (TEMP) will be responsible for working closely with the Cell Therapy Manufacturing team to support documentation development for the buildout of a state-of-the-art GMP cell therapy manufacturing plant.

The Operations Technical Writer (TEMP) is responsible for the creation of batch records for use in GMP manufacturing of cell therapy products, materials specification and deviations. This position will work cross-functionally with Manufacturing, Process and Analytical Development, Quality, Project Management, 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 Role

  • Edit and write manufacturing User Requirements, Specifications, Protocols, Reports, and other supporting documents
  • Collaborate with area SMEs and/or Technical Specialists to create or revise existing procedures or documents for use in the manufacturing processes
  • Monitor and track documentation status against key timelines and milestones and manage prioritization
  • Writes, edits, and reviews manufacturing documents, validation protocols, SOPs, and development-related material, while maintaining standardized and consistent documentation practices for recording details of new processes for the manufacture of cell therapy products
  • Worked collaboratively with Manufacturing, Facilities, Process and Analytical Development, and Quality to support the implementation of cGMP commercial manufacturing processes by developing new systems, procedures, and documentation.
  • Authored and revised documentation to be used during cGMP operation, including but not limited to Standard Operating Procedures (SOPs), Work Instructions (Wis), Forms, and Templates
  • Supported cGMP Manufacturing through the establishment of Quality Management System
  • Worked with internal teams to obtain an in-depth understanding of the process and documentation requirements
  • Produced high-quality documentation that meets applicable standards and is appropriate for its intended audience
  • Migrated and revised Standard Operating Procedures (SOPs) for Facilities (for new equipment and batch manufacturing)
  • Created Master Batch Records (MBRs) and Solution Manufacturing Procedures (SMPs), interacting with departments and customers as necessary
  • Developed and assembled batch-related documentation and completed reviews before the transfer to Quality Assurance
  • Interacted with Production/Facilities personnel on continuous improvement projects related to processes, procedures, and other assignments
  • Performed a thorough gap analysis of all documentation related to Material Qualifications, including Change Controls, Risk Assessments, Specifications, Analytical Reports, and Test Methods
  • Write/develop deviations, investigations, and CAPAs

The Candidate

  • Bachelor's Degree in Life Sciences preferred with a minimum of 5+ years of direct industry experience, cell therapy preferred
  • 5+ years' experience writing deviations, investigations, CAPAs, change control in GMP Operations, manufacturing or production operations and rewriting and revising GMP batch records
  • 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.
  • Ability to effectively communicate with internal departments and customers.
  • Strong written and verbal communication skills required
  • Ability to read, understand, and interpret technical instructions is required



"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here"


Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.