M-F Full Time
Reports to: Manager of Downstream Process Development or Higher Management
Scope of Function:
1) Transfer protein purification and characterization assays from the client and perform relevant characterization of proteins within the CMO environment. Characterize protein purification and protein bio-conjugation process. Provide technical expertise in addressing scientific and technical problems related to characterization in the process Development department
2) Characterize and evaluate the stability of protein in several formulations being developed
3) Work with assay qualification and validation group to develop, verify and qualify assays
1) Perform protein characterization and in-process assays as required such as ELISA, SDS PAGE, IEF, HPLC, WESTERN, BCA, capillary electrophoresis, cell based assays, spectrofluorometeric and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards in support of tech transfer and process development activities
2) Evaluate emerging techniques in protein characterization for the production of biotherapuetics and develop assay as required.
3) Possess good understanding of bio-chemical and bio-physical characterization of the primary, secondary, tertiary and quaternary structures of recombinant proteins and monoclonal antibodies
4) Write SOPs and record all laboratories activities and results in appropriate note books.
5) Develop formulation and stability of antibodies and recombinant proteins
6) Lead the coordination of activities and communication to assure efficient and timely transfer of assays to Quality Control and manufacturing group
7) Assist Quality Control Group in trouble shooting assays where appropriate
8) Effectively interact and assist other groups within the Development groups (cell culture, protein purification, and bio-conjugation) and the Quality/Regulatory and Manufacturing groups on assay and process related matters
9) Interact with Clients and make recommendations and resolutions of assay and process being developed
10) Communicate project status with Clients, Project Management and Senior GBI Management as needed
11) Must be able to manage multiple projects
12) Evaluation and estimation of Technical aspects of protein characterization assays and processes to Sales and Marketing group for the generation of project proposals and quotes for new and existing clients
Education, Experience and Skills required:
Education: BSc, MSc or PhD in biological or biochemical sciences.
Experience: 5 - 8 years relevant laboratory experience in antibody/protein purification and bio-conjugation development and characterization, particularly in the areas of immunology, molecular and cell biology and protein chemistry. Experience in assay qualification, validation and GMP manufacturing compliance is required.
Skills: This individual is expected to provide expertise in the area of protein characterization and therefore must be able to work independently with little to no direction. Experience with protein/antibody purification and bio-conjugation is required. Must be flexible and able to work on multiple projects at the same
time. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Good communication, documentation and computer skills
Quality Assurance, Quality Control, Regulatory Affairs, Project Management, Materials Management, Purchasing, Client, Senior Management, Process Development Scientists, Manufacturing.