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Vigene Biosciences Technical Writer in Rockville, Maryland

Title: Technical Writer

Department: Tech Transfer & Support

Reports To: Director, Tech Transfer & Support

Location: Rockville, Maryland

Company Overview:

Vigene Biosciences, Inc. is an award winning CDMO that provides viral vector-based gene delivery services and products for research and clinical applications. We are proud to support scientists at any stage of research: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes thousands of scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

Job Summary:

The technical writer will collaborate closely with the scientific Subject Matter Expert (SME), initiating, drafting, and preparing the first draft of assigned documents on SOPs, batch records, technical reports, specification, change control, deviation, root analysis, and CAPA in the GMP campaign.

Essential Duties & Responsibilities:

Provide editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency while maintaining adherence to proper formatting and regulatory requirements

Author and assist in technical transfer documentation and detailed process descriptions, SOPs, batch records, and campaign summary reports

Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from SME to senior management

Create and execute protocols that support technical transfer and GMP manufacturing

Perform documentation gap analyses and develop plans for writing requirements

Other responsibilities as needed

Non-Essential Duties & Responsibilities:

n/a

Supervisory Responsibilities:

n/a

Knowledge and Other Qualifications:

Ph.D. in Chemistry, Virology, Biochemistry, Biophysics, Molecular Biology, or related field with 2 years of experience; or

M.S. in the same fields with 5 years of experience; or

B.S. in the same fields with 8 years of experience

Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory

Other Characteristics:

Attention to detail while completing multiple projects and documents at once

Basic knowledge of cell culture, purification, and analytical methods

Experience creating deliverables such as standard operating procedures (SOPs), batch manufacturing records (BMRs), protocols, and other technical reports

Demonstrated ability to manage complexity and handle/prioritize multiple tasks

Knowledgeable of FDA regulations, and FDA and ICH guidance documents

Authorized to legally work in the United States without visa sponsorship

Physical Requirements/Work Environment/Travel Requirements:

Must be able to lift up to 15 lbs.

Standing, sitting, pushing, pulling

Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

Job Type: Full-time

COVID-19 considerations: We have established multiple policies to protect our employees' health & safety while allowing essential operations to continue following social-distancing & PPE guidelines. Non-essential departments are working remotely and/or working alternative hours.

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