Principal Researcher, Downstream Process Development - Biologics
$80,200–$105,200 year
On-siteExton, Pennsylvania, United States
Job Summary
Execute laboratory scale experiments for protein purification including chromatography, filtration, and membrane separations. Investigate novel technologies to improve processes, perform standard analytical methods such as UV/Vis spectroscopy, HPLC, and ELISA, and design viral clearance studies. Support internal and external technology transfers, author regulatory documents, and maintain critical data in laboratory notebooks. Perform scale-up and tech transfer of purification processes for GMP production and manage PD equipment and laboratory maintenance. Interact cross-functionally with Upstream Process Development, Operations, and Quality Assurance to support late-stage product development.
Required Qualifications
- BS or MS in biological sciences, chemistry, biochemistry or equivalent job experience/degree
- Minimum 5 years' experience with protein purification techniques for biopharmaceuticals
- CMC protein purification development experience with standard bioprocess unit operations such as chromatography separations (resin/membrane: affinity, CEX, AEX, HIC, MM) and filtration operations (depth filtration, virus filtration, sterile filtration, TFF)
- Extensive experience with AKTA chromatographic instruments
- Unicorn method writing experience for systems such as AKTA Avant and AKTApilot
- Excellent attention to detail and ability to keep detailed written records
- Ability to author clear and concise technical reports and presentations
- Demonstrated ability to independently design, execute, and interpret experimental data to further process/product knowledge
Desired Qualifications
- Experience in Design of Experiments (DoE) and multivariate analysis
- Experience with high throughput screening techniques, including Tecan
- Knowledge or experience with scale-up, technology transfer, process validation, viral clearance studies, and GMP manufacturing
- Experience with analytical techniques such as HPLC, electrophoresis and ELISA
- Strong written and oral communication skills and good interpersonal skills
- Team player who can excel in fast-paced entrepreneurial environment
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