Senior Engineer, Upstream Process Development
JOB PURPOSE
We are seeking a talented and motivated individual to join the Upstream Early Process Development group as a Senior Engineer. This role will lead upstream process development of one of our gene therapy programs through phase 1. This role is for a hands-on leader and mentor who will be the viral vector process development expert on our team 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.
We are seeking a talented and motivated individual to join the Upstream Early Process Development group as a Senior Engineer. This role will lead upstream process development of one of our gene therapy programs through phase 1. This role is for a hands-on leader and mentor who will be the viral vector process development expert on our team 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
- Lead tech transfer to the Pilot plant and CMO and support GMP operations
- Lead cross-functional teams in tech transfers and process validations
- Responsible for 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 7+ years of experience in manufacturing sciences, process development, manufacturing, or related areas. Or PhD with relevant 2+ years academic or industry experience in these areas
- Demonstrated deep understanding of viral vector process development, characterization, manufacturing, and relevant biology. (AAV, Lentiviral vector, or other viral vector therapeutic modalities)
- 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
- 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.