Vigene Biosciences Fill Finish 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: The Fill Finish Team Lead will work as part of a team to provide leadership, guidance, and assistance on operations and activities associated with Fill Finish such as filling, capping, labeling, gathering, and preparation of equipment and materials. The role of Fill Finish Team Lead is to apply a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical stage medicines to dramatically improve the human condition through gene therapy. The job encounters recurring work situations of a routine nature where the ability to recognize a deviation from accepted practice is required. Essential Duties & Responsibilities: Perform basic to complex activities in dispensing of Drug Substance and Fill-Finish of Final Drug Product Demonstrate understanding of systems, equipment, and processes Document all operations with strict adherence to cGMP documentations practices (Batch Records, Logbooks, Forms, etc.) Effectively communicate and interface with team to ensure the completion of daily activities. Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs) Exercise intellectual curiosity by identifying and escalating events and subtle variances that deviate from normal operation Teach aseptic techniques and monitor others to assure aseptic technique is properly followed in a production environment Participates in incident investigations, deviations, and corrective and preventive action (CAPA) Interact with other departments to complete activities associated with Fill-Finish operations Prepare buffers and solutions to support Fill-Finish operations as needed Create, edit, and review Production Batch Records and Standard Operating Procedures Assist staff in developing new procedures and methods or improving old ones Provide training to junior team members Demonstrated ability and understanding of Safe working habits and Material Safety Data Sheets (MSDS) Prepare buffers at large scale (≥ 20L) Perform other tasks as assigned that ensures sustainable right-first-time performance Other responsibilities as needed Non-Essential Duties & Responsibilities: n/a Supervisory Responsibilities: Fill Finish Manufacturing Associates Knowledge & Other Qualifications: Bachelor of Science in science and at least 5 years of experience in Fill-Finish operations in Biopharmaceuticals Manufacturing Industry; or High School Diploma or Associate Degree with 7-10 years of experience in Fill-Finish operations in Biopharmaceuticals Manufacturing Industry Other Characteristics: Technical understanding of Fill-Finish operations for biologics products, including aseptic process simulations and qualifications Understanding of operating in an aseptic environment Hands-on experience with manual and semi-automated filling apparatus Proven ability to consistently and independently follow policies and procedures, instructions, and to meet schedules Ability to troubleshoot basic mechanical operations Ability to demonstrate problem solving and critical thinking Organization and planning skills Ability to work in a Team and collaborative environment Knowledge and skill to recognize creative ideas that add value and can be implemented to improve efficiency, effectiveness and reduce complexity for department Attention to detail and time management Ability to work in a fast-paced environment with changing priorities Basic computer skills such as proficiency with Microsoft Office Suite to support the operation in its daily functions Ability to write and adhere to internal written procedures Ability to multi-task and prioritize to meet strict deadlines Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending) 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 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.