This position will serve as a technical expert with extensive knowledge of advanced principles, theories and concepts in the area of purification. The Senior Scientist will have a broad knowledge of protein purification and will incorporate the best of industry practices into daily work.
Initiate, design, execute and implement purification development for therapeutic protein programs
Development of robust, scalable, cost effective and well-characterized processes for purification of monoclonal antibodies and recombinant proteins, including improvement of platform purification processes
Provide technical advice of purification process development, supervise research associates to perform bench scale to pilot scale production to demonstrate process performance
Work with minimal supervision, analyze and interpret data, and present/document the results at meetings, Provide reports and prepare scientific presentations as needed. Write/revise batch records and technical reports.
Interact with senior members of the other functional groups including those in Upstream Process, Analytical Development, Quality people.
Provide technical advice and guidance to the purification group; evaluate and incorporate the best practices into the work setting
The candidate must have strong technical knowledge and substantial hands-on experience on recombinant protein and antibody purification process development in the industry and have deep understanding about different aspects of purification process development.
Good experimental design skills (e.g.DOE) is a requirement. Ability to critically analyze data using statistical tools and to compile technical reports
Comfortable with a team effort approach in solving technical problems and also be able to contribute with independent thinking
Effective oral and written communication skills are essential, evidence of effective supervisory skills is required.
Demonstrated ability of innovative thinking and problem solving based upon sound scientific principles and logic reasoning
Experience with process technical transfer from development into cGMP manufacturing is highly desired, preferably having some tech support experience at commercial scale
Previous working experience in CRO/CMO setting is desired, experience with customer is highly preferred
Understanding of the Drug Discovery process and the application of QbD principles are highly desirable.
Good cGMP knowledge and experience in the pharmaceutical industry is preferred
Familiarity with mammalian, microbial and yeast protein expression is a plus
Education and experience requirements:
PhD in a scientific discipline and a minimum of 5 years’ progressive experience or an MS with 8+ years’ progressive experience in biopharmaceutical purification process development
Excellent knowledge of scientific principles and concepts is also required