Careers at Vigene
Headquartered in Rockville, Maryland, Vigene Biosciences is a rapidly growing company that strives to be a leading manufacturer of viral vectors. We are proud to support researchers at any stage of development: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.
We are passionate about our mission to help support scientists advance their biomedical research and ultimately to make gene therapy affordable and available to those in need. As we continue to grow, we are always looking for talented people to join our team who share our passion. We value our employees as important contributors to our mission, so we provide opportunities for career growth and encourage employees to develop new skills so they can grow with our company.
Equal Opportunity Employer
Vigene Biosciences is an EEO/AA employer. 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. If you need reasonable accommodation for any part of the employment process, please contact us by email at email@example.com and let us know your request and contact information. Please note that only inquiries concerning a request for reasonable accommodation will be acknowledged from this email address. Requests for accommodation will be considered on a case by case basis.
- Healthcare benefits (Medical and Dental/Vision Insurance)
- 100% Company Paid Life Insurance
- 100% Company Paid Accident Insurance
- Short and Long Term Disability Insurance
- Paid Vacation, Floating Holidays and Sick Leave
- 401(k) Plan with Safe Harbor Match
- Employee Assistance Program
- Dependent Care and Commuter/Transit FSA
- Adoption Assistance
- Education Assistance
- Competitive Salary and Performance Bonus
- Career development opportunities
- Work-Life Balance
- Fun, collaborative environment
- Job Title
- Technical Writer
- Rockville, MD 20850
- Other Location
Title: Technical Writer
Department: Manufacturing Science & Technology (MSAT)
Reports To: Senior Director, MSAT
Location: Rockville, Maryland
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.
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:
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
- 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
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.
- Required Skills