Excellent employment opportunity for a Sr. Research Associate II, Viral Vector Downstream Process Development in the Santa Monica, CA area.
Will be an integral member of the downstream process development of the viral vector programs at company, contributing to the development, scale up and technology transfer of the viral vector production process.
These activities can include ultrafiltration, microfiltration, chromatography, depth filtration, impurity characterization, scale-down model development and qualification, process optimization, robustness studies, and process characterization.
In addition, this individual in collaboration with our technical operations group will support process technology transfer activities, due diligence and facility fit assessment for internal and external manufacturing facilities.
Support development of downstream technology platforms to improve vector recovery, purity and stability.
Design and execute process development studies to develop a thorough understanding of operating and performance parameters and identify process efficiencies to be made.
Perform normal flow and tangential flow filtration operations, chromatographic separations, in-process analytical testing (UV spectroscopy, HPLC, gel electrophoresis, ELISA, turbidity) as required.
Develop manufacturing processes for viral vector products and support process scale up and implementation into GMP clinical production suites
Perform process analysis and trend process performance
Write and review technical documentation
Selects appropriate methods and techniques in performing research and process.
Collaborates with colleagues to develop methods.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Acts as a resource for other employees within the department.
Maintains familiarity with scientific literature and applies appropriately to research projects.
Demonstrates strong verbal communication skills and interpersonal skills.
Works with collaborative communication and problem-solving spirit.
5+ years of experience with BS Degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
2+ years of experience with MS Degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline
Previous experience with TFF ultrafiltration for Biologics or viral vectors is required.
Experience with the development of viral vector purification process trains is desired.
Previous experience with Molecular Biology and Biophysical techniques (ELISA, HPLC, gel electrophoresis, PCR, particle size determination) is desired.
Experience with statistical experimental design (i.e., DOE studies) and automation technologies is desired.
Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired.
Excellent interpersonal, verbal and written communication skills are essential.
Knowledge of chromatography (i.e., modes of operation, column packing/qualification), ultrafiltration, scale-up and engineering principles (e.g., residence time, critical flux, proper dimensions for scaling-up)
Hands on expertise with laboratory-scale FPLC instruments (i.e., AKTA/Unicorn) and TFF/NFF systems (i.e., PendoTECH).
Previous experience running molecular biology assays (ELISAs, gel electrophoresis, flow cytometry) is desired.
Demonstrated excellence in viral vector or biologics downstream process development, process technology transfer, scale translation, and statistical DOE (design of experiments)
Excellent communication and presentation skills and aptitude for problem solving
Experience with the preparation of regulatory filings for US and external markets is desired
ELISA,cGMP manufacturing,HPLC,MOLECULAR BIOLOGY,ELISAs,Biophysical techniques,TFF ultrafiltration,viral vectors,laboratory-scale FPLC instruments,AKTA/Unicorn,TFF/NFF systems