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Research Scientist II Protein Purification

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Location
CA
Salary
$80,000 - $125,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jan 01, 2017
Job ID
2409412
Hands-on technical leadership in design and execution of purification process development, optimization, scale-up, validation/characterization, process transfer activities, and GMP manufacturing support for early and late stage protein therapeutics. ? Strong understanding of technical processes, including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.? Oversee and delegate experimental/project responsibilities, independently champion technology development projects, participate in new product evaluation, and define and implement purification process platforms.? Mentors and directs research associates and members of project teams in the initiation and execution of laboratory experimentation, considering appropriate economic, regulatory and safety factors. ? Transfer processes from development to clinical and commercial GMP manufacturing, including definition of bill of materials, batch record drafting/review, and discrepancy resolution. ? Provide technical troubleshooting and identify opportunities for future process and equipment improvements. The candidate may be expected to travel to support tech transfer and manufacture operations. ? Author, review, and approve development reports, batch records, regulatory filings, and process validation and characterization reports. ? Serve as a sub-team functional lead - highly proactive, collaborative; effectively engage in technical discussions and communicate potential issues, solutions, timelines and deliverables. Responsible and accountable for developing biologics processes for the manufacturing of drug substances.? Becomes familiar and hands-on with Pilot Plant operations and non-GMP manufacture. Able to write master batch records and development summaries independently.PhD w/3+ years or MS/BS w/extensive experience.

Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.