Maintain accurate and timely data records and documentation in both ELN and paper systemsAuthor or participate in peer reviewed publication of scientific work as well as patent applications when appropriate
The Senior Engineer I/ II, Upstream Manufacturing Support, is a new position, created to provide strong leadership as Oncobiologics continues its rapid growth. The Senior Engineer I/ II, Manufacturing Support, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center.
The Facilities and Engineering Director is responsible for leading the Facilities Organization for Building Operations, GMP Manufacturing and Process Development Facilities support, Maintenance Management, Facilities Planning, and Environmental Health & Safety Management.
The Director, MTS, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center, including Tech Transfer and scale-up technical support.
Senior Scientist, Cell & Molecular Biology, will be responsible for the molecular biology work to prepare expression constructs, conduct cell line development, and write appropriate technical documents related to the development of biosimilar monoclonal antibody and protein molecules.
As part of this overall goal, the candidate would be required to perform routine and non-routine testing, perform the method development and validation of the physicochemical test methods, and create and execute experimental plan which assess the physicochemical stability of biological drug candidates.
Senior Scientist, Biophysical Characterization, will be responsible for the development, qualification, validation and technical transfer of robust biophysical test methods for biosimilar monoclonal antibodies.
Approval of cGMP documentation as it relates to downstream manufacturing inclusive of SOPs, Batch Records, Deviations, Change Controls, Equipment Qualification Protocols, Technology Transfer Protocols, and Process Validation Protocols.
Director, Cell Culture Process Development, will be responsible for the strategy, development and characterization of robust cell culture processes for biosimilar monoclonal antibodies including micro- to pilot scale bioreactor equipment and filtration processes (e.g. depth).
Principal Scientist, Bioassay Development, will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.