Green Key Resources is seeking a Technical Writer for a biotech organization in Rockville, MD. This position will work closely with scientific Subject Matter Experts to initiate, draft, and prepare the first draft of assigned documents on SOPs, technical reports, and records, changed control, deviation, and root analysis. The responsibilities for this role include the following:
· Provide editorial support ensuring the quality of the scientific content, focusing on clarity, accuracy, and consistency while maintaining proper formatting and regulatory requirements.
· Author and assist in technical transfer documentation and detailed process description, SOPs, batch records, and campaign summary reports.
· Initiate and manage rounds of document reviews and make revisions by interacting with all levels of reviewers.
· Create and execute protocols that support technical transfer and GMP manufacturing.
· Perform documentation gap analysis and develop plans for writing requirements.
· Master’s degree in Chemistry, Biochemistry, Virology, Biophysics, Molecular Biology, or related field with 5 years of experience or Ph.D. in the same fields with 2 years of experience
· Experience in cGMP regulated environment and/or large-scale bioprocessing laboratory
· Attention to detail while completing multiple projects
· Basic knowledge of cell culture, purification, and analytical methods
· Experience creating deliverables such as SOPs, BMRs, protocols, and technical reports
· Knowledge of FDA regulations and FDA and ICH guidance documents
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