CMC Technical Writer - Innovative Gene Therapy Start Up

Foster City, California, United States · CMC

Description

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.


Responsibilities

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.


Requirements

Job Requirements

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

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