Principal Engineer, Downstream Process Modeling

Summit Strategic Search•Somerville, NJ

9d•$145,000 - $192,000•Hybrid

About The Position

Our client is a global biotechnology company developing cell therapies across several platforms, with programs that run from early research through commercial supply. The company has R&D and technical operations teams in multiple countries and continues to invest in new delivery approaches, including in vivo cell therapy. The Opportunity Our client is adding an engineer to its Technical Development organization to bring a model driven approach to viral vector downstream development. You will build mechanistic and hybrid models of purification steps, pair them with focused lab studies, and use them to design processes that hold up at GMP scale. You will work closely with the downstream, upstream, and analytical development leads, and your models will inform process design, tech transfer, and regulatory documentation. The client will consider candidates at the Senior or Principal level. Final title and scope will reflect experience, technical depth, and track record.

Requirements

PhD (preferred) or MS in Chemical Engineering, Bioprocess Engineering, Biomedical Engineering, Bioengineering, or a related field.
6+ years (PhD) or 8+ years (MS) in process development, MSAT, or manufacturing in biotech or pharma.
Principal level candidates will bring additional experience and technical leadership.
Hands on downstream process development experience, including chromatography, TFF, and clarification.
Strong engineering skills in process simulation, mechanistic or in silico modeling, process design, and DoE.
Working knowledge of GMP requirements and CMC strategy for clinical stage products.
Strong troubleshooting, communication, and collaboration skills.
Candidates must be authorized to work in the United States.

Nice To Haves

Viral vector downstream experience (lentiviral, AAV, adenoviral, or other), or downstream experience with viral vaccines or gene therapies.
Python and/or MATLAB, plus familiarity with chromatography or bioprocess modeling software.
Experience applying AI or machine learning to bioprocess development.
Exposure to in vivo cell therapy or systemic delivery programs.
Purification experience at 50L scale or larger.
Experience with advanced process control or digital twin approaches.

Responsibilities

Develop mechanistic and hybrid models of viral vector purification unit operations and use them to guide development decisions.
Ground models in first principles engineering, including transport phenomena, fluid dynamics, and thermodynamics.
Design and analyze DoE studies, and use data science and machine learning methods to find patterns and process insight in development data.
Collaborate with the downstream team on clarification (depth filtration, centrifugation), chromatography (anion exchange, size exclusion, hydrophobic interaction), and TFF steps.
Combine simulation with lab work to move bench processes into GMP manufacturing, and support troubleshooting during clinical manufacturing campaigns.
Develop process control approaches, such as model predictive control and soft sensors, to improve process consistency.
Improve vector yield, purity, and potency through new technologies and creative problem solving.
Partner with upstream and analytical development so that the full process performs as one integrated system.
Support technology transfers between internal sites and external manufacturing partners.
Write and review development reports, SOPs, and CMC content for regulatory filings.
Surface technical risks early with clear mitigation options, and help leadership identify ways to accelerate programs.
Advise scientists and cross functional colleagues on modeling and engineering questions, and work within applicable regulatory requirements.