Manufacturing Associate I, Plasmid Production
Vigene Biosciences, A Charles River Company Rockville, MD
- Posted: over a month ago
DEPARTMENT: Plasmid Production
REPORTS TO: Manager, Facilities and Engineering
LOCATION: Rockville, MD (5-Research)
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.
As a member of plasmid manufacturing team, the Manufacturing Associate I applies a broad knowledge of biological, bioprocess, and mechanical principles to execute manufacturing protocols in a regulated and controlled environment. Performs in-process analysis of plasmid production.
Duties and Responsibilities
- Perform basic upstream activities in seed train, bioreactor set up, fermentation monitoring, and harvest
- Perform basic downstream activities such as cell lysis, chromatography, TFF, and final formulation steps
- Perform in-process plasmid analysis
- Document of all activities in Batch Records, Logbooks, Forms, etc.
- Follow verbal and written procedures in operating production equipment and performing processing steps accurately. Timely completion of appropriate production documentation
- Exercise basic problem-solving skills and reporting observed process variances that deviate from normal operation to senior members of group in a timely manner
- Participate as needed in process investigations to determine root cause and effect for process deviations
- Monitor processes using automated production systems and controls under the guidance of manufacturing associate II or III
- Prepare, sanitize, and disinfect equipment to prevent microbial contamination
- Demonstrate ability to troubleshoot basic mechanical operations with input from senior manufacturing associates
- Operate upstream/downstream process equipment, perform process methods, and prepare buffers with supervision
- Ability to operate process equipment, perform laboratory procedures, data analysis, and complete documentation with training
- Responsible for documenting in real time process steps in batch records/work instructions and submitting completed documents to Manufacturing Associate II/III for review.
- Responsible for collecting and storage of in-process and final bulk product samples as per current manufacturing procedures
- Perform daily tasks as per manufacturing schedule and communicating task status to Manufacturing Associate II/III
- Perform other tasks as assigned that ensures sustainable right-first-time performance and satisfies client customers
- Other responsibilities as needed
Qualifications for the Job
- B.S. in Science or Engineering with 1 year experience in a Biotech or related industry, or equivalent experience
- Basic understanding of purification methods from cell culture processes
- Familiarity with the following: Upstream - bioreactors (Wave, BioFlo 120, XDR, and fermenters), Aseptically perform seed and fermenter inoculation, sampling and harvesting. Downstream - column chromatography (Affinity, IEX, HIC), buffer preparation, and Tangential Flow Filtration (TFF)
- Able to work under supervision performing basic upstream and/or downstream tasks
- Detail oriented with strong organizational skills
- Collaborate with Manufacturing Associate II on performance daily tasks. Responsible for the completion of daily tasks as per manufacturing schedule
- Previous work in plasmid production desired but not required for position
- Demonstrates integrity and respect
- Delivers results
- Demonstrates business acumen
- Fosters collaboration and teamwork
- Champions change
- Flexible work hours – must be willing to work outside of normally-scheduled hours when needed
- Standing, (sometimes prolong standing), sitting, pushing, pulling, walking, bending, stooping, and kneeling
- Able to lift up to 35lbs.
Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant based on 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.
Vigene Biosciences, A Charles River Company
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