Vigene Biosciences Scientist, Final Fill in 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.
Implements knowledge and expertise to successfully execute virus Process Development (PD) projects for AAV, lentivirus, adenovirus, and/or other biologics products
Essential Duties & Responsibilities:
Conduct independent process development and execute the operational procedures for Aseptic/Sterile Fill Finish from development to cGMP manufacturing activities
Troubleshoot complex drug product fill problems. Lead the formulation/fill finish tasks. Identify issues and propose adequate solutions.
Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as they relate to the Fill Finish Operation
Work with PD, Quality Control, and Quality Assurance for sampling plan and equipment requirements
Participate in decision-making processes within the project team by actively engaging in scientific and technical discussions
Effectively communicate results of own work through scientific meetings, presentations, discussions, documentation, and with clients
Cross train as needed with the manufacturing team
Utilize and apply knowledge of Drug substance and product release criteria with knowledge on Q-PCR, Western blot, SDS-PAGE, ELISA, DLS, sterility LAL assays, and HPLC to lead product specification
Other responsibilities as needed
Non-Essential Duties & Responsibilities:
Knowledge and Other Qualifications:
Master s Degree with 5 years of experience, or Ph.D. with 1-2 years of experience in Chemistry, Virology, Biochemistry, Biophysics, Molecular Biology, or related field
Working experience with final fill and virus production is preferred
Excellent verbal and written communication skills
Microsoft Office experience (Word, Excel, PowerPoint, etc.)
Good critical thinking skills
Ability to resolve customer issues
Well-organized, able to manage multiple projects at a time
Strong ability to adapt, be flexible, and work independently and with resilience
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.