Biological Processes, Chromatographic Systems, Chromatography, Cleanroom, Communication Skills, Computer Skills, Contract Manufacturing, Current Good Manufacturing Practice (cGMP), Editing, GMP (Good Manufacturing Practices), Gene Therapy, High School Diploma, Manufacturing, Microsoft Excel, Microsoft Management Console (MMC), Microsoft Word, Production Control, Production Systems, Standard Operating Procedures (SOP)
Join Our Team in Rockville, MD - Downstream GMP Manufacturing Role
Are you passionate about making a difference in the field of gene therapy? Join our team in Rockville, MD, where you'll work in a dynamic environment dedicated to improving the human condition through innovative purification processes. This role offers the opportunity to work directly in activities associated with purification, applying your knowledge of biological, bioprocess, and mechanical principles in a cGMP environment. If you thrive in a fast-paced setting and are committed to excellence, we want to hear from you!
Responsibilities
- Perform downstream purification activities such as Chromatography, Tangential Flow Filtration (TFF), Ultracentrifugation, and Final Formulation steps.
- Work in a cleanroom environment, adhering to Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
- Prepare, sanitize, and disinfect equipment to prevent microbial contamination.
- Monitor processes using automated production systems and controls under supervision.
- Prepare buffers and solutions needed for downstream activities, including large scale.
- Document all activities in Batch Records, Logbooks, and Forms.
- Communicate effectively with the team to ensure the completion of daily activities.
- Interact with other departments to complete activities associated with downstream operations.
Requirements
- High School Diploma or Associate Degree with 0-2 years of experience in downstream biologic production processes in a GMP environment, or
- Bachelor of Science in Science or Engineering with 0-1 years of experience in downstream biologic production processes in a GMP environment.
- Ability to work flexible hours and in a fast-paced environment.
- Must be able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours.
- Must have reliable transportation to travel between sites in the Rockville area.
Preferences
- Experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single-use mixing systems.
- Experience in the preparation of buffers and editing/reviewing Production Batch Records and SOPs.
- Previous work in viral or vaccine production and experience working for a Contract Manufacturing Organization (CMO).
- Strong communication skills and basic computer skills including Microsoft Word, Excel, and Teams.
Call to Action: Ready to take the next step in your career? Apply now to join our team in Rockville, MD, and contribute to groundbreaking work in gene therapy!
Subject Line: Exciting Opportunity: Downstream GMP Manufacturing Role in Rockville, MD
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