Qualifications: PhD/MS/BS in Biochemistry, Chemistry, Chemical Engineering or equivalent
Experience:Minimum 5+ years of experience in absence of graduate degree, 2+ years if MS, or entry level PhD; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement. Strong knowledge of both preparative and analytical chromatography required.
This position will report to the Head of Purification Development with the responsibilities including (but not limited to):
A. Purification Development (50%)
Represent purification development in team meetings as required.
Develop purification platform process and associated analytical in-process analytical through the application of design of experiment for rapid speed to First in Human Studies.
Implement state of the art science and technology for screening chromatography resins and other separation techniques including automated liquid handling systems.
Collaborate with other functions to deliver an efficient low cost solution to customers.
Execute and design experiments while maintaining a current laboratory notebook with scientific rigor to meet project needs for process development.
Evaluate Protein-A, Ion Exchange, Hydrophobic Interaction chromatography resins and other separation techniques for rapid process development and protein separation modeling.
Develop scalable chromatography methods that minimize types of buffers and maximize efficiency of operations in manufacturing.
Have core competency in filtration including methods for cell culture/fermentation clarification, tangential flow filtration and viral clearance.
Execute process development enabling analytics required to make development decisions rapidly. Should have experience with HPLC/UPLC, electrophoretic, ELISA and SPR technologies and equipment.
B. Equipment and Facilities (30%)
Participate in starting up facility and process equipment. Work to deliver state of the art technologies specifically around liquid handling systems for high-throughput process development.
Develop efficient and innovative solutions to enable multi-host development and cGMP facility design and operation.
Follow full GMP guidance and fulfill all regulatory requirements where necessary.
Operate safely and according to company environmental requirements.
C. Culture (20%)
Evaluate technologies and propose ideas for innovation.
Support business development activities as required.
Present data or ideas in team meetings.
Follow all company best practices to minimize cost and meet budgetary requirements.
Head of Purification Development may assign other responsibilities as required.
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