Unclassified - Durham, NC

posted 4 months ago

Full-time - Mid Level
Durham, NC

About the position

Join us in reimagining Cell and Gene Therapies and advancing scientific breakthroughs for patients with unmet medical needs. We transform the lives of people by developing innovative and life-changing medicines. The Expert, Science & Technology (Downstream) is responsible as a technical lead in gene therapy downstream process development for designing and executing downstream process development activities, as well as performing downstream process operations at both small scale and large scale to support pipeline research and pre-clinical studies. Your responsibilities will include, but are not limited to: advancing complex downstream process development efforts as a technical lead within a cross-functional team, independently designing and executing gene therapy downstream process development studies, and performing experiments at both large-scale and small-scale to support pre-clinical, clinical, and commercial programs, ensuring these experiments are done in a timely fashion with high quality. You will stay current with the latest scientific and engineering developments in the field, leveraging a strong understanding of biologics downstream processes to evaluate and introduce new technologies and innovative ideas related to downstream process development. Additionally, you will analyze and interpret experimental data from process studies with a strong statistical mindset, making decisions based on statistically sound conclusions. Presenting study results internally and externally in a cross-functional setting, you will independently author technical reports for process development activities and laboratory experiments. Collaboration with cross-functional groups to advance pipeline programs will be essential, providing support for regulatory filings and authoring sections in IND filings. Multiple positions are available.

Responsibilities

  • Advances complex downstream process development efforts as a technical lead within a cross-functional team.
  • Independently designs and executes gene therapy downstream process development studies.
  • Performs experiments at both large-scale and small-scale to support pre-clinical, clinical, and commercial programs, ensuring these experiments are done in a timely fashion with high quality.
  • Stays current with the latest scientific and engineering developments in the field.
  • Leverages strong understanding of biologics downstream process to evaluate and introduce new technologies and innovative ideas related to downstream process development.
  • Analyzes and interprets experimental data from process studies with strong statistical mindset, making decisions based on statistically sound conclusions.
  • Presents study results internally and externally in a cross-functional setting.
  • Independently authors technical reports for process development activities and laboratory experiments.
  • Collaborates with cross-functional groups to advance pipeline programs, providing support for regulatory filings and author sections in IND filings.

Requirements

  • Bachelor's degree in biological sciences, pharmaceutical sciences, chemical engineering or related technical field with 4 years relevant experience, Master's degree with 2 years of experience, or PhD with 0-2 years of experience.
  • Comprehensive experience with a variety of biopharmaceutical purification processes such as chromatographic separation, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance.
  • Proficient in statistical analysis principles and approaches.
  • Working knowledge and experience with Design of Experiment (DoE).
  • Ability to analyze data to make data-driven decisions and further progress development strategies.
  • Proven team leader with previous experience of effectively leading technical group.
  • Innovative with a continuous improvement mindset.
  • Good communication skills with project management experience in cross-functional setting.

Nice-to-haves

  • Knowledge of viral gene therapy and previous experience with AAV or LVV downstream process development is a plus.
  • Knowledge of current Good Manufacturing Practices (cGMP) requirements and their indication in process development environment is a plus.
  • Experience with mechanistic modeling a plus.

Benefits

  • 401(k) eligibility
  • Various paid time off benefits, such as vacation, sick time, and parental leave
  • Sign-on bonus
  • Restricted stock units
  • Discretionary awards
  • Full range of medical and financial benefits
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