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8 days old

Senior Scientist, MSAT, Orange County, CA

Kelly Services
Tustin, CA 92781
_Fast track the process and apply today! Qualified talent will be contacted within 24 hrs._


**Senior Scientist, MSAT, Orange County, CA**


Kelly Science is recruiting for a leading bio-pharmaceutical for an experienced Senior Scientist in the Orange County area. This is a great opportunity for someone with 5-10 years of industry experience to join a growing company and support innovative therapies. _*Will consider_ **_remote_** _candidates who can work periodically onsite.*_


**Overview**


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.


**Type:** Direct-Hire

**Compensation:** Annual Salary and Bonus, Stock Options, Benefits

**Shift:** 1st, M-F


**Responsibilities**


+ 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.


**Position Type/Expected Hours of Work:**


This role is a full-time exempt Monday - Friday position. Must be available to work holidays, weekends or extended hours if necessary to support production schedule. Will consider remote candidates who can work periodically onsite.


**Qualifications**


+ 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.


**Questions? Email JEND557@kellyscientific.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. 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: 2021-02-19 Expires: 2021-03-22

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Senior Scientist, MSAT, Orange County, CA

Kelly Services
Tustin, CA 92781

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