This position is primarily responsible for establishing needed quality assurance processes and leaning existing quality assurance processes. This includes the revision or initiation of SOPs that accurately reflect the lean process and training of QA staff and external personnel on the new/revised lean process.
The Quality Assurance Incoming Associate will oversee the receipt, sampling and release of incoming raw materials and components as part of the Quality Systems within cGMP operations performed at Oncobiologics.
Senior Scientist/Principal 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. Methodologies include but are not limited to FACS Aria operation, Celigo, Octet and Ella. She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the cell line development of biosimilar antibodies or proteins.
The main mission of the Biochemical Characterization group in Analytical Sciences is the development and validation of physicochemical methodologies and assays for process-related impurities. As part of this overall goal, the candidate would be required to develop methodologies, create experimental plans, and execute studies which assess the physicochemical stability of biologic drug candidates. This includes generating, documenting, and analyzing data for team and senior management discussions and development reports.
Biophysical Characterization group is responsible for the development, qualification, validation and technical transfer of robust physicochemical test methods for biosimilar monoclonal antibodies, and sample testing to support biosimilarity assessment and formulation/process development. Methodologies include but are not limited to DSC, CD, FT-IR, HIAC, MFI, AUC, HPLC and mass spectrometry. She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.
Consult with internal departments and working with the business groups, consults with external customers to identify customer needs and include into project objectives.Asses needs to develop new systems and improve existing program designs.
Lead a multi-disciplined group responsible for process engineering, equipment qualification, tech transfer, and process scale-up
Manage creation of RFP's and URS' for customized automation and integration of packaged systems such as single use bioreactors and upstream equipment, chromatography systems, TFF systems, and depth filtration systems
opening for Principal Scientist in Biochemical Assay Development. The main mission of the group is the development, validation, and transfer of physicochemical methodologies and process-related impurity assays. As part of this overall goal, the candidate would be required to lead the method development and validation, represent the group in cross-functional project team meetings, train and coach junior scientists, perform non-routine testing, and create and execute master method validation plan and experimental plan which assess the physicochemical stability of biological drug candidates.