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Scientist III/Sr. Scientist, Process and Analytical Development

Site:
Houston, TX
Department:
Process and Analytical Development
Reports to:
Associate Director, Process and Analytical Development
Overview
    • We are currently looking for a highly motivated Scientist III/Sr. Scientist, specializing in AAV-based gene therapy to join our Process and Analytical Development team. The Scientist III/Sr. Scientist, Process and Analytical Development is responsible for Houston PAD lab startup activities, with a strong focus on downstream process development, execution and technology transfers. The incumbent will benchmark against industrial and existing PD / AD capabilities within PackGene, lead new project implementation and execution in a timeline driven manner.
Roles and responsibilities include, but are not limited to
      • Participate in planning and hands-on execution of initial lab startup activities, including new equipment acquisition, coordinating with various vendors to ensure smooth transition into full lab operation.
      • Hands-on experience in downstream unit operations such as chromatography, tangential flow filtration and ultracentrifugation, etc.
      • Downstream process development experience of viral vectors or protein/antibody therapeutics is strongly preferred.
      • Maintain a high level of technical acumen in the field of viral vector purification and formulation process.
      • Participate in discussions with clients and serve as a downstream subject matter expert (SME).
      • Work with a cross-functional team to perform technology transfers into GMP.
      • Design and execute process and analytical development studies, involving suspension and adherence platform downstream process.
      • Design and execute process and analytical development studies, involving suspension and adherence platform downstream process.
      • Coach of junior associates /scientists on experimental rationale, design, execution and troubleshooting.
      • High level of accountability, integrity and communication; foster a culture of collaboration, trust, and teamwork.
      • Build strong, cohesive working relationships with colleagues across the company to accomplish goals.
Qualifications
      • Ph.D. in Biology, Biotechnology, Engineering, or other gene therapy related field.
      • 5-8+ years of industrial experience in Biologics development, including protein, antibody, and viral vectors (AAV, or lentiviral vector).
      • Proficient in QbD based approach utilizing Design of Experiments (DOE).
      • Working knowledge of GMP, FDA-regulated industry.
      • Demonstrated ability to work cross functionally in multi-disciplinary team work.
      • Working knowledge of key assays used in viral vector release and characterization, including PCR, ELISA, SDS-PAGE and cell-based assays will be a plus.
      • Proficient in MS Office suites of products.
      • Ability to multitask, prioritize work independently.
      • Capable of analyzing problems and finding solutions.
      • Ability to work under pressure while maintaining a professional.
      • Other duties as assigned.
Other Qualifications
      • Problem solving and analysis skills. Scientists need to be able to develop and analyze the results.
      • Math skills
      • Communication and writing skills. Must be able to communicate their progress and findings both orally and in written form to their team, managers, customers and in public forums. They also must document process, keep records, describe findings, and make recommendations in published reports and presentations.
      • Teamwork skills. Most scientific problems are complex and often best solved in teams.
      • Planning skills. Need to plan projects and map out a timeline.
Work Conditions
      • Onsite location with occasionally sitting at a desk as well as frequently walking and standing in the lab to perform mix experiment work.

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