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Vigene Biosciences Upstream GMP Manufacturing Team Lead in Rockville, Maryland

Department: GMP Manufacturing Reports to: Senior Manager, GMP Manufacturing 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: Leads a team and works directly with a range of bioreactor and recovery technologies such as single-use systems (adherent and suspension), filtration technologies (TFF and depth), and centrifugation, following aseptic techniques and procedures in a cGMP environment. Essential Duties & Responsibilities: Ensure safety of manufacturing area and work practices Provide leadership, guidance, and direction to staff to create a quality-centric organization Coordinate and plan upstream manufacturing floor activities Create, edit and review Production Batch Records and Standard Operating Procedures Oversee and prepare upstream buffers/media aliquots in accordance with procedures Perform various filter integrity tests throughout the process Assist Technical Transfer and Support in preparing Batch Production Records (BPRs) Ensure team members are qualified to execute GMP manufacturing Coordinate and implement project safety and quality assurance programs in collaboration with internal partners Ensure proper documentation and execution of Batch Production Records for assigned projects by actively participating in batch production Participate in and/or lead incident investigations May perform as subject-matter expert (SME) or system owner for specific downstream equipment Responsible for providing training to new upstream associate and overseeing their training requirements. Interact with other departments to implement approved process improvements Monitor processes using automated production systems and controls with limited supervision Engage in equipment preparation, sanitation, and disinfection Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance Non-Essential Duties & Responsibilities: n/a Supervisory Responsibilities: Upstream Manufacturing Associates Knowledge & Other Qualifications: Bachelor of Science and at least five (5) years of Biopharmaceutical Upstream Manufacturing experience: on-the-floor leadership or “subject matter expertise” in cGMP Manufacturing Other Characteristics: At least 5 years of experience with Upstream Operations in the Biopharmaceuticals Industry – single-use bioreactors, aseptic technique, product recovery (centrifugation, clarification, depth filtration, etc.) At least 5 years of experience in the preparation of media and buffers at large scale (≥ 20L) Preparation of material for autoclaving and operation of autoclave Ability to operate manual and semi-automated in support of routine production with minimal supervision Ability to work and lead in a team and collaborative environment Great attention to detail, time management, and project management Previous experience working for a Contract Manufacturing Organization (CMO) preferred Previous experience working in Process Development Role (Upstream) 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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