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1+ months

Sr. Scientist (MSAT) - Irvine, CA

Kelly Services
Tustin, CA 92781
**Sr. Scientist MSAT - Irvine, CA**


**Summary/Objective:**


The MSAT Sr. Scientist's primary responsibilities are to provide scientifically sound innovative strategies and validation approach to existing and new processes through its lifecycle. This requires strong scientific knowledge (both theoretical and practical) in recombinant protein development and manufacturing to understand how changes or variants may impact product quality. The MSAT Sr Scientist provides analysis of data from both internally and externally generated sources to provide recommended strategies.


**Technical Duties/Responsibilities & Essential Functions:**


+ Communicate with clients on proposed strategies and process assessments

+ Evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.

+ Prepare analysis and reports of proposed changes that are based on sound scientific and engineering principles.

+ Perform statistical analysis of data to form conclusions and recommendations.

+ Author Technical Reports and Process Validation Protocols

+ Provide scientific justification for risk assessments and product impact statements. Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.

+ Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale.

+ Recommend and drive improvements in equipment, processes, and systems to increase efficiency and reduce risk.

+ Monitor Process Health through process monitoring.

+ Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions.


**Education and/or Experience:**


+ PhD or M.S. in scientific or engineering (chemical, mechanical or biomedical) discipline. Minimum 5-10 years of biologic manufacturing process development.

+ Demonstrated track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.

+ Strong knowledge of cGMPs or equivalent standards.

+ Ability to make sound decisions to resolve or escalate deviations and/or issues on the production floor.

+ Ability to speak effectively before groups of customers or employees of organization.

+ Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-15 Expires: 2021-05-03

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Sr. Scientist (MSAT) - Irvine, CA

Kelly Services
Tustin, CA 92781

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