Scientist I/II, PD Downstream

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in needs. We focus on tackling key challenges in gene therapy development, including viral vector production and specific targeting, mRNA technologies, and GMP production at scale.

Requirements

• Participate in planning and hands-on execution of lab operation activities, including new equipment acquisition, training and maintenance.
• Hands-on execution of downstream unit operations such as clarification and filtration, tangential flow filtration (TFF), chromatography purification with AKTA system and ultracentrifugation unit operations.
• Downstream process development and operation experience of viral vectors or protein/antibody therapeutics is strongly preferred.
• Maintain a high level of technical acumen in the field of viral vector downstream process.
• Participate in client meetings and serve as a downstream process subject matter expert (SME).
• Work with a cross-functional team to perform technology transfer of downstream procedures into GMP.
• Ability to pass gowning training and support GMP operations in cleanrooms
• Design and execute downstream development studies, involving suspension and adherence platform process. Occasional weekend work may be required.
• Perform timely data acquisition, analysis and troubleshooting; report project progress in cross-functional team meetings.
• Ability to troubleshoot process and equipment, and support deviation investigations and make scientifically sound decisions
• Draft and review technical documents such as protocols, technical reports, and risk assessments.
• Ability to perform scientific review of master batch records and SOPs.
• Ability to create and review Unicorn methods for accuracy.
• Ensure timeline adherence

Benefits

• Health insurance
• Retirement plan
• Paid time off
• Vacation time