MSAT Scientist – Cell Therapy Tech Transfer and Production
Germantown, MD
Full Time
Mid Level
Job Title: MSAT Scientist – Cell Therapy Tech Transfer and Production
Location: Germantown MD
Company: uBriGene Biosciences
About Us:
uBriGene is a leading CDMO specializing in cell and gene therapy manufacturing. We are committed to delivering high-quality products to support clinical and commercial pipelines in the biotech industry.
We are looking for a highly motivated MSAT scientist to join our team and play a critical role in cell therapy product tech transfer in a cGMP environment. If you are passionate about cutting-edge biotechnology and thrive in a fast-paced environment, this could be the perfect role for you.
Key Responsibilities:
Why uBriGene?
At uBriGene, we offer an innovative and collaborative work environment where you will contribute to the cutting-edge development of cell and gene therapies. We are passionate about fostering professional growth and delivering impactful solutions for our clients.
Location: Germantown MD
Company: uBriGene Biosciences
About Us:
uBriGene is a leading CDMO specializing in cell and gene therapy manufacturing. We are committed to delivering high-quality products to support clinical and commercial pipelines in the biotech industry.
We are looking for a highly motivated MSAT scientist to join our team and play a critical role in cell therapy product tech transfer in a cGMP environment. If you are passionate about cutting-edge biotechnology and thrive in a fast-paced environment, this could be the perfect role for you.
Key Responsibilities:
- Play a key role coordinating with internal and external stakeholders to transfer end-to-end engineered cell therapy manufacturing process including the tumor tissue dissociation, target cell isolation, transduction, expansion, harvest and fill/finish and cryopreservation operation into cGMP clinical production.
- Serve as process subject matter expert to collaborate with internal key stakeholders including process development, analytical development, QC, manufacturing team, logistics, regulatory affair and quality assurance to provide sound tech guidance to drive successful clinical production
- Able to identify available cutting-edge technologies to drive cell therapy process optimization and scale-up solutions to reduce clinical production cost of goods.
- Serve as process technical subject matter to author technical reports and CMC related regulatory sections to support regulatory submission and provide tech support to address regulatory inquires
- To provide tech training and coach junior team members including manufacturing operators to execute the manufacturing process in PD labs and cGMP facility.
- Serve as a process subject matter expert to lead process deviation investigation, impact assessment and author related reports
- Serve as a process subject matter expert to support cGMP operation and process/manufacturing fit assessment/gap analysis of equipment, facilities and processes.
- Track trending clinical production performance to drive process improvement including process performance and operation to drive production cost reduction as well ensure the process operation within intended control strategy.
- PhD in cell biology, engineering, molecular biology, pharmaceutical chemistry or a related discipline with 1-3 years wet lab experience (academic or industry) or master’s degree with minimal 3 years of industry experience or minimal 5 years industry experience for BS
- Industry experience and strong hands-on skills in cell therapy process development and tech transfer are required. Direct experience in Tumor-infiltrating lymphocyte (TIL) therapy is strongly preferred.
- Demonstrated experience and hands-on skills in tumor tissue dissociation, cell isolation, transduction, expansion and cryopreservation operation in PD and cGMP environment
- Demonstrated knowledge and understanding of cGMP requirements, ICH and regulatory guidelines
- Demonstrated ability to drive sound decision-making in the cGMP environment
- Experience in cell analytical method development and qualification including flow cytometry, qPCR and cytotoxicity assay is strong plus
- Organizational, multi-tasking and communication skills
- Able to collaborate and a good team player
- Able to work in a fast and dynamic environment
Why uBriGene?
At uBriGene, we offer an innovative and collaborative work environment where you will contribute to the cutting-edge development of cell and gene therapies. We are passionate about fostering professional growth and delivering impactful solutions for our clients.
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