Associate Scientist II, Internal RD & PD

Associate Scientist II, Internal RD & PD

Summary:

Catalent Cell and Gene Therapy is looking to recruit an Associate Scientist II, Internal RD & PD to join our growing team in Baltimore, MD.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Viral Vector R&D Product Development supports Product innovation to keep Catalent at the forefront of other leading CDMOs.  We have expertise in a variety of areas including Cell-line, and Vector Development, Upstream and downstream Process innovation.   We have developed several licensable products to date for novel modalities (viral therapies, mRNA, iPSCs, cell-therapy, exosomes,).  In addition, this Innovation team participates in due diligence evaluation of partners, vendors, and potential acquisition targets.  Within Biomodalities, the C&GT business unit continues to develop technology in-house and evaluates potential external offerings. For scale-up, the late-stage teams collaborate with scientists from Manufacturing Science and Technology (MS&T) to support tech transfer for Drug Substance development and fill finish (Catalent or client developed processes).  In addition, we offer pre-clinical development to customers and partner with our late-stage PD groups to further the product.  Scientists joining our team will have the opportunity for career development as Catalent continues to grow.

Reporting to a Senior Scientist for daily supervision, the Associate Scientist II – Viral Vector R&D and Product development, will work independently as well as collaboratively within our growing team in Biopark, MD.  The individual should bring technical knowledge, initiative, strong scientific integrity, and enthusiasm for learning to make measurable contributions within the group.  The role will involve cross-training on Platform technologies, along with development and execution of various chromatography scale-down models for AAV, LVV, and Plasmid DNA.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

This is a full-time on-site position, Monday – Friday 8:00am-5:00pm

The Role:

• Executes experiments to develop and improve scale-down purification processes using mammalian, and/or insect cell culture suspension, or Plasmid harvests.
• Collaborates with, and communicates with downstream, PD, along R&D colleagues and keeps them informed of purification projects.
• Evaluates new methods, techniques, and technology platforms, and undertakes equipment demos as part of continuous process improvement. Keeps current with advances in downstream processes for AAV, LVV, and Plasmid production.
• Authors and reviews lab SOW, process descriptions, technical reports to document study outcomes, and justify process changes, and/or process updates.
• Cross-trains on Fermentation, and High-throughput technologies for providing needed support
• Performs execution of cell line screening experiments using a high-throughput mini bioreactor system ambr, clone expansion and cell banking.
• Completes experimental records according to Good Documentation Practices.
• Enters and analyzes data, supports project leads in generation of reports and presentations.
• Manages samples and inventory related to each experiment.
• Assists with lab maintenance, stocking, cleaning, and troubleshoots equipment.
• Stay up to date with required trainings and operates within established systems, helps improve systems.
• Other duties as assigned.

The Candidate:

• B.S. in a biological discipline (biochemistry, molecular biology, cell biology or related field) with 3+ years of experience
• M.S. in a biological discipline (biochemistry, molecular biology, cell biology or related field) with 1+ years of experience
• Practical experience in Downstream Process and techniques, instrument care, maintenance, tro