Bioprocess Associate I, Upstream, Manufacturing Science & Technology
Vigene Biosciences | Rockville MD
JOB TITLE: Bioprocess Associate I, Upstream, Manufacturing Science & Technology DEPARTMENT: Manufactur...
JOB TITLE: Bioprocess Associate I, Upstream, Manufacturing Science & Technology DEPARTMENT: Manufacturing Science & Technology (MS) REPORTS TO: Director, MS LOCATION: Rockville, MD (5-Research) General Job Description Vigene Biosciences has been a leader at the forefront of cell and gene therapy, Adeno-Associated virus or AAV vector production, adenovirus vector production, lentivirus vector production, retrovirus vector production, plasmid production, viral vector QC and analytical services, plasmid QC and analytical services, providing services and products to support this rapidly growing and increasingly important field. The Bioprocess Associate I, Upstream, MS, will transfer product and process knowledge between development and manufacturing to ensure right-first-time clinical and commercial manufacturing and continuous improvement. Those processes include buffer and media preparation, upstream, and aseptic fill-finish. Duties and Responsibilities Interact with Process Development (PD), GMP Manufacturing, Facilities, Quality Control (QC), Quality Assurance (QA), and Procurement to ensure project success Perform GMP operation per batch records if needed such as buffer preparation, cell counts, mammalian cell culture and transfection, virus manufacturing, and harvest per TFF, and filter integrity testing Assist on GMP campaign summary reports and review manufacturing documents (batch records, SOPs, and deviation reports, etc.) Work with procurement, development, and QA to ensure timely material generation requirements and procurement to fill the need for GMP production, including drug substance and/or drug product final container components Work with facility team and QA team to ensure the readiness of equipment and GMP facility for GMP production Create user requirement specifications (URS) document for new equipment Cooperate with vendor, facility, and QA on new equipment IQ/OQ Demonstrate ability and understanding of Safe working habit and Material Safety Data Sheet (MSDS) Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs) Document of all operations with strict adherence to cGMP documentation practices in Batch Records, Logbooks, Forms, etc. Monitor GMP Operations to ensure batch records and parameters control Analyze the process performance for control and data integration Other responsibilities as needed Qualifications for the Job B.S. in Chemical or Biomolecular Engineering, Cell Biology, Bioengineering, Biotechnology, or related field with at minimum of 0-2 years of R experience M.S. in Chemical or Biomolecular Engineering, Cell Biology, Bioengineering, Biotechnology, or related field with at minimum of 0-1 years of R experience Previous experience working for a Contract Manufacturing Organization (CMO) preferred Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory Experience with cell culture or viral-based production including bioreactor operation Proven ability to work independently and to multi-task, manage multiple projects simultaneously Excellent teamwork, collaboration, interpersonal and communication skills (both verbal and written) Organizational and planning skills Ability to work in a Team and collaborative environment Attention to detail and time management Basic computer skills in Microsoft (Word, Excel, Teams etc.) Ability to work in a fast-paced environment Key Competencies Demonstrate integrity and respect Delivers results Demonstrates business acumen Champions change Engages and inspires Working Conditions ????Must be able to lift up to 50 lbs. Standing (sometimes prolonged standing), sitting, pushing, pulling, walking, bending, stooping, kneeling Able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours Flexible work hours – must be willing to work outside of normally-scheduled hours as necessary 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. 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.