Contract Process Development Associate II

This role is responsible for providing overall support in early stages of process development and acting as an interface with the Research and CMC organizations. This person will be responsible for executing and developing stage appropriate downstream processes for novel protein therapeutics. Developing downstream purification processes for expression scales that range from shake flasks to pilot scale bioreactors. Theis person will also be involved in providing and analyzing data and relevant information for reports supporting tech transfer activities for external manufacturing.

Responsibilities:

• Hands-on execution, and optimization of protein purification processes including primary recovery unit operations (centrifugation, homogenization, flocculation, tangential-flow filtration (TFF), and depth filtration), chromatography (ion-exchange, affinity, hydrophobic interaction), and pre-formulation (TFF, dialysis)
• Generate and analyze process and analytical data supporting key documents such as development reports, regulatory submissions, and technology transfer packages
• Execute routine scale down protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software)
• Perform analyses including but not limited to UV-Vis Spectroscopy, SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary
• Buffer preparation and aseptic technique
• Drug substance and protein intermediate inventory management
• Work within the DSP group to explore novel purification processes as well as using standard methods to purify proteins
• Perform small-scale studies and pilot scale purification studies
• Apply DOE methods to purification activities
• Executing protocols, interpretation of data, and report generation
• Work with Co-Ops and helping them in their planning and activities as needed
• Maintain laboratory notebooks and digital records
• Present data at process development and CMC department meetings
• Operate and troubleshoot process equipment
• Chromatography, TFF including, UD/DF, micro filtration, nano filtration, and filtration
• Process scaling and/or technology transfer

Qualifications

• B.S. (Graduate degree preferred MS and PhD) in Chemical Engineering, Biochemical Engineering, or an equivalent engineering/science degree with 1-3+ years of experience working in the biopharma industry.
• Experience in protein purification, scale up/down, process and analytical characterization
• Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems is a plus
• Comprehension of downstream processes at the small to an intermediate scale of cGMP biologics production
• Familiarity with automated chromatography platforms (e.g., Cytiva AKTA)
• Ability to work independently and as part of a cross-functional team
• Good oral and written communication skills
• Ability to adapt to frequent change and thrive in a dynamic early-stage environment
• Strong communication and organization skills, knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively.