Scientist I, Purification

Just-Evotec is seeking a motivated and creative scientist or engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. As adownstream process design scientist/engineer, you will join a fast-paced, collaborative, and multidisciplinary team to developpurification processes for low-cost mammalian cell derived antibody biotherapeutic manufacturing. Process design at Just-Evotec means exposure to innovative technologies like plate-based purification screening, high throughput and automated robotic screening, continuous processing technologies for a first-of-its-kind flexible and reconfigurable manufacturing facility. 

The successful candidate will have exposure to DoE principals and analysis, an understanding of mammalian cell derived impurities and monoclonal antibody product quality attributes, and an understanding of chromatography and filtration theory. The ideal candidate will also have experience executing chromatography on an AKTA Avant/Pure using some or all of the following resin types: Affinity, IEX, HIC, and MM.The successful candidate will also have experience operatingsome or all of the following: Depth filtration, viral filtration, ultrafiltration/diafiltration (UFDF) via conventional tangential flow filtration (TFF), and in-line concentration (ILC) and in-line diafiltration (ILDF) via single pass tangential flow filtration (SPTFF). The ideal candidate has strong written and verbal communications skills, technical report writing experience, works well -independently and in groups, confident in presenting data and experimental design for internal presentations, and continually looks for ways to improve processes and technology.Experience with ELNs, protocol writing, DoE structure and analysis, high throughput chromatography screening, chromatography mechanistic modeling, multicolumn chromatography, late stage characterization, validation studies, and manufacturing deviation support is a plus.

Responsibilities:

• Work on a team to develop purification processes for biotherapeutics manufacturing and complete ICH compliant late stage validation studies with focus on continual downstream processing

• Able to problem solve at the benchtop and quickly reach satisfactory solution

• Accurately record data in electronic notebooks, execute and manage complex sample plans, and communicate with coworkers about complex execution

• Chromatography and filtration buffer compounding, AKTA Avant/Pure maintenance and advanced operation, Unicorn software method writing and program execution, column packing and testing

• UV/Visprotein concentration measurements via spectrometer, SoloVPE, & Lunatic

• Train junior employees and become laboratory resource for expert knowledge on selected topics/equipment

• Technical report writing that supports downstream process definition and CTDs that includedata analysis

• Interface with Manufacturing Sciences and Technology (MSAT) group for process transfer to manufacturing facilities and manufacturing groups for deviation support

• Technology development to reduce cost and improve efficiency of purification processes and expand Just-Evotec’s end to end continuous process

Position Requirements:

• BS or MS degree in Engineering, Biochemistry, or related field and 5+ years of experience or Ph.D.

• Knowledgeable in chromatography and filtration theory, downstream development strategy,and process scale-up and manufacturing transfer

• Experience developing Affinity, IEX, HIC, and MM chromatography with AKTA purification systems

• Experience developing normal and tangential flow filtration operations

• Knowledgeable about mammalian cell derived process impurities and monoclonal antibody product quality metrics

• Excellent written and verbal communication skills

• Experience with design of experiments (DOE) and analysis using statistical software packages (JMP, MATLAB, etc.)

Additional Preferred Qualifications:

• Experience with multi column chromatography

• Experience with continuous and connected processing

• Experience with chromatography process modeling

• Experience with late stage validation studies and ICH regulations

• Experience with transfer to manufacturing facilities and manufacturing deviation support