Principal Investigator, Purification Sciences
Proclinical is currently recruiting for a Senior/Principal Research Investigator of Purification Process Sciences for a pharmaceutical company located in Wilmington, DE. Successful candidate will provide technical expertise in protein purification process development, characterization, and validation primarily for novel therapeutic monoclonal antibody products including bispecifics throughout all stages of clinical trials.
- Conduct purification process development including viral clearance studies, scale-up, and technology transfer to CMO or internal manufacturing facility
- Conduct purification process characterization and validation
- Conduct high-throughput protein purification to support cell line and cell culture development
- Conduct routine analyses of in-process samples using relevant product purity and process impurity analytical tools
- Manage laboratory supplies and instrument maintenance
- Write routine electronic laboratory notebook and development reports
- Present updates in routine cross-functional project team meetings
- Participate in critical review of manufacturing batch records and deviations
- Participate in writing and reviewing the CMC sections of IND and BLA documents
- Other responsibilities as assigned
Skills and Requirements:
- PhD in biochemistry, bioengineering, biology, chemistry or related fields with a minimum of 5 years of relevant industry experience or a MS degree with a minimum of 8 years of relevant industry experience
- Fundamental knowledge in protein chemistry, bioprocessing, and cGMP
- Fundamental knowledge and hands-on experiences in various types of column/membrane chromatography (affinity, size exclusion, ion exchanges, HIC, multi-mode) and filtration technology (TFF and nanofiltration) for cell culture harvest and clarification, protein purification and analysis
- Experiences in protein purification process development, characterization, and validation for manufacturing biologics drug substances
- Experiences in using UF/DF instrument for buffer exchange, product concentration, and formulation
- Experiences in purification process viral clearance studies
- Experiences in purification process scale-up and technical transfer to manufacturing
- Experiences in using AKTA line of purification instruments from lab scale to pilot scale
- Experiences in using analytical instruments for protein analysis such as HPLC, capillary electrophoresis, SDS-PAGE, ELISA, light scattering, etc.
- Excellent verbal and written communication skills
- Cooperative, independent, capable of critical thinking and multi-tasking
- Experiences in Design Of Experiment approach and high-throughput protein purification platform, in interactions with regulatory, QA, QC, and CMO, and in writing CMC section of IND and BLA documents will be a plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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