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Vigene Biosciences Downstream GMP Manufacturing Associate II in Rockville, Maryland

Department: GMP Manufacturing Reports to: Downstream GMP Manufacturing Team Lead Location: Rockville, MD 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 Downstream GMP Manufacturing Associate II will work as part of a team and work directly in activities associated with purification that apply a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. The activities will take place in a cleanroom following aseptic techniques and procedures in a cGMP environment. Essential Duties & Responsibilities: Perform Downstream purification activities such as Chromatography, Tangential flow filtration (TFF), Ultracentrifugation, and Final Formulation steps Prepare, sanitize, and disinfect equipment to prevent microbial contamination Monitor processes using automated production systems and controls with supervision Obtain and perform in-process sampling Prepare buffers and solutions needed for Downstream activities Perform various filter integrity tests throughout the process Document of all operations with strict adherence to cGMP documentation practices in Batch Records, Logbooks, Forms, etc. Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation Effectively communicate and interface with team to ensure the completion of daily activities Operate manual and semi-automated equipment in support of routine production with minimal supervision Prepare buffers at large scale (≥ 20L) Edit and review Production Batch Records and Standard Operating Procedures Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs) Interact with other departments to complete activities associated with Downstream operations Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance Non-Essential Duties & Responsibilities: n/a Supervisory Responsibilities: n/a Knowledge & Other Qualifications: High School Diploma or Associate Degree with 3-7 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company; or Bachelor of Science in science or Engineering and 2-4 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company Other Characteristics: Technical understanding of purification processes from cell culture processes Hands-on experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single-use mixing systems Ability to operate manual and semi-automated equipment in support of routine production with minimal supervision Experience in the preparation of buffers at large scale (≥ 20L) Experience editing and reviewing Production Batch Records and Standard Operating Procedures Organizational and planning skills Ability to work in a Team and collaborative environment Attention to detail and time management Previous work in viral or vaccine production highly desired Previous experience working for a Contract Manufacturing Organization (CMO) preferred Communication skills in English language (writing, speaking, comprehending) Basic computer skills - knowledge of Microsoft® Word and Excel Authorized to legally work in the United States without visa sponsorship Physical Requirements/Work Environment/Travel Requirements: Operations are 24 hours per day, 7 days per week, and shift work will be required Must be able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours Must be able to work flexible hours – must be willing to work outside of normally-scheduled hours as necessary Must have reliable mode of transportation to travel between sites in the Rockville area Must be able to lift up to 50 lbs Standing, (sometimes prolong standing), sitting, pushing, pulling, walking, bending, stooping, kneeling 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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