Vigene Biosciences Fill Finish GMP Manufacturing Associate II in Rockville, Maryland
Department: GMP Manufacturing Reports to: Fill Finish 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 Fill Finish Manufacturing Associate II applies 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. Essential Duties & Responsibilities: Perform basic to complex activities in dispensing of Drug Substance and Fill-Finish of Final Drug Product Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation Document all activities in 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) Prepare buffers and solutions to support Fill-Finish operations as needed Perform other tasks as assigned that ensures sustainable right-first-time performance and delights client customers Perform preparation of buffers at large scale (>20L) Edit and review Production Batch Records and Standard Operating Procedures Perform other tasks as assigned that ensures sustainable right-first-time performance Demonstrate ability and understanding of Safe working habit and Material Safety Data Sheet (MSDS) Other responsibilities as needed 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 Fill-Finish operations in Biopharmaceuticals Manufacturing Industry; or Bachelor of Science with 2-4 years of experience in Fill-Finish operations in Biopharmaceuticals Manufacturing Industry; or Other Characteristics: Technical understanding of Fill-Finish operations for biologics products, including aseptic process simulations and qualifications Hands-on experience with manual and semi-automated filling apparatus Hands-on experience in large scale (≥ 20L) buffer preparation Organizational and planning skills Ability to work selflessly in a Team and collaborative environment Attention to detail and time management Communication skills in English language (writing, speaking, comprehending) Basic computer skills in Microsoft Office (Word, Excel, SharePoint, Teams etc.) Ability to troubleshoot basic mechanical operations Ability to work in a fast-paced environment Authorized to legally work in the United States without visa sponsorship Physical Requirements/Work Environment/Travel Requirements: Ability to work with hazardous waste and laboratory chemicals 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.