Senior Research Associate, Upstream Process Development
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
QUALIFICATIONS
Basic Qualifications
Preferred Qualifications
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.
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.