Senior Research Associate, Upstream Process Development

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JOB PURPOSE

We are seeking a talented and motivated individual to join the Upstream Early Process Development group as a Senior Research Associate. This role will contribute to upstream process development of our gene therapy programs through phase 1. This role is for a creative and inquisitive engineer or scientist who will become a viral vector process development expert and drive establishment of our novel viral vector manufacturing modality.

DUTIES AND RESPONSIBILITIES
  • Develop robust and industrialized platforms and phase 1 processes for manufacturing novel viral vectors for gene therapies
  • Use manufacturing experience to identify, optimize, and characterize key process parameters Perform screening DoE studies to confirm the impact of process parameters on yield and product quality attributes
  • Implement innovative, next generation technology for manufacture of viral vectors
  • Support tech transfer to the Pilot plant and CMO and support GMP operations
  • Support cross-functional teams in tech transfers and process validations
  • Support authoring documentation such as batch records, sampling plans, and development reports
  • Maintain a functioning bioprocess lab including equipment maintenance and critical supply management

QUALIFICATIONS

Basic Qualifications
  • BS/MS in Chemical Engineering or a related field with 2+ years of experience in manufacturing sciences, process development, manufacturing, or related areas.
  • Hands-on experience with bioreactor unit operations at bench and pilot scale
  • Demonstrated ability to work successfully in teams
  • Excellent communication, documentation, and presentation skills
  • Working knowledge of DoE methods for experimentation and statistical analysis

Preferred Qualifications
  • Demonstrated understanding of viral vector process development, characterization, manufacturing, and relevant biology. (AAV, Lentiviral vector, or other viral vector therapeutic modalities)
  • Experience with gene or cell therapy development
  • cGMP gene or cell therapy manufacturing experience
  • Demonstrated ability to work with and lead cross-functional teams and manage projects
  • Tech transfer and working with CMOs
  • Familiar with FDA and EU regulations and GMP standards.

Working Conditions

This is a lab-based role, with occasional weekend work. Some travel may be required including tech transfer and CMO-related work.

Physical Requirements

Able to lift up to 50 lbs.