Summary:
Performs downstream process development experiments and supporting activities, which enable both early and late-stage manufacturing process design for therapeutic monoclonal antibody production via yeast and mammalian expression systems.
Essential Functions:
- Performs small-scale downstream process development experiments for monoclonal antibodies, as applied to liquid chromatography and tangential/normal flow filtration.
- Prepares experimental intermediate samples for further analytical testing, including purification via miniature liquid chromatography and ultrafiltration devices.
- Prepares purified protein product to support upstream process development and supply further downstream process development activities.
- Performs analytical methods, such as UV-visible spectrophotometry, turbidimetry, density measurement, size exclusion and protein A affinity HPLC, and biolayer interferometry.
- Organizes and analyzes primary data and prepares concise presentations and reports.
Required Education, Experience, and Skills:
- Accredited bachelor's degree and a minimum of 2+ years of biotechnology/pharmaceutical industry experience or equivalent combination of education and experience totaling 4 years.
- Basic understanding of the principles of liquid chromatography, membrane filtration, sedimentation/centrifugation, aqueous physical chemistry, and protein chemistry.
- Familiar with basic laboratory equipment, including pH, conductivity, & temperature meters, pumps, pressure gauges, weight scales, pipette dispensers, and tabletop centrifuges.
- Excellent verbal communication skills to interact collaboratively with Process Development teammates.
- Well-developed organizational skills and the ability to take a proactive approach to job responsibilities.
- Ability to comply with FDA GMP documentation regulations and industry standard safety practices.
- Proficiency in Microsoft Windows 10/Office.
- Must be able to lift to 30 pounds on occasion.
Preferred Qualifications, Skills and Competencies
- An accredited B.S. degree in science or engineering (i.e. Biochemical Engineering, Chemical Engineering, Biotechnology Engineering, Biochemistry, Biotechnology or equivalent).
- Experience with analytical techniques such as HPLC, UPLC, and/or CE a plus.
- Experience with pilot scale operations a plus.
- Experience with MPLC systems such as the Äkta/Unicorn platform a plus.
