Job Summary (Primary function):
Essential Functions of the Job (Key responsibilities):
- Lead purification process development including viral clearance studies, scale-up, and technology transfer to CMO or internal manufacturing facility
- Participate in BLA-enabling purification process characterization and validation studies
- Perform analysis of in-process samples using relevant product purity and process impurity analytical tools as needed
- Write development, characterization, validation, and tech transfer 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 needed
Qualifications (Minimal acceptable level of education, work experience, and competency):
- 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, multi-mode) and filtration technology (depth filtration, TFF, and nanofiltration)
- Experiences in purification process development, characterization, and validation for manufacturing biologics drug substances
- 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
- Excellent verbal and written communication skills
- Experiences in Design Of Experiment methodology, in interactions with regulatory, QA, QC, and CMO, and in writing CMC section of IND and BLA documents will be preferred
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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