CMC Technical Writer - Innovative Gene Therapy Start Up
The Technical Writer will support the Chemistry, Manufacturing, and Controls (CMC) Team by authoring and subsequent maintenance of technical documentation related to the development and commercialization of Orchard Therapeutics’ innovative gene-modified cell-based therapeutic products. Such activities will include authorship, subsequent maintenance, and revisions of SOPs, technical procedures, protocols, and reports related to laboratory operations, development and validation activities, manufacturing processes and analytical methods.
Writing technical documents, such as but not limited to general laboratory operations, manufacturing, and analytical procedures, protocols, and reports in a GxP regulated environment. Work closely with Orchard’s Quality Assurance (QA) Document Control group for document number assignment, filing, and maintenance. Additional co-ordination with Regulatory Affairs may be necessary to ensure maintenance of the accuracy of information in documents. Must be able to interact cross-functionally with internal groups, contract manufacturing organizations (CMOs), collaborators, and business partners to ensure required information is accessible and organized. Other technical document related tasks may be assigned.
The ideal candidate for this position will have a proven track record of authoring technical documents in a GxP environment for fast-paced programs developing innovative biotechnology products.
Education & skills
- A minimum BS degree, or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences and 4 years of relevant biotechnology or pharmaceutical industry experience.
- General knowledge of current Good Manufacturing Practices (FDA, EMEA, and ICH guidance)
- Performs work with a high degree of accuracy and quality while working under tight deadlines.
- Demonstrates strong verbal, written, and interpersonal communications skill with the ability to explain complex concepts with clarity and simplicity.
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Adobe Acrobat Professional.
- Direct knowledge of manufacturing processes and/or assay development, characterization, and validation requirements a plus.