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7 days old

MSAT Engineer/ Medical Science Liaison (Upstream)

Kelly Services
Tustin, CA 92781
**Title:** MSAT Engineer/ Medical Science Liaison (Upstream)


**Location:** Tustin CA


**Job Overview:**

The MSAT Engineer s primary responsibilities are to ensure successful transfer and execution of new processes in Manufacturing and be the main point of contact for clients and internal depts for technical support. This requires knowledge in scaling processes, understanding of Mfg equipment limitations, and setting up the Manufacturing Operations for success. The MSAT Engineer also drives process improvement to increase efficiency and decrease risk.


**Technical Duties/Responsibilities Essential Functions:**


+ Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

+ Communicate with Client on Process Status and collaborate to resolve issues on the floor.

+ Provides technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.

+ Authors Manufacturing Batch Production Records, Technical Reports, and Process Validation Protocols

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

+ Perform proper equipment and facility fit assessment for new processes or process changes to ensure proper execution

+ Monitor Process Health through process monitoring.

+ Author Risk Assessments to identify gaps and identify areas of improvement

+ Provide technical training to Manufacturing Operators

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

+ Conduct systematic investigations of root causes or problems or identified risks

+ 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.

+ Ability to perform statistical analysis of data to form conclusions and recommendations.

+ Perform other duties as assigned.


**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.


**Education and/or Experience:**


+ B.S./M.S. in scientific or engineering chemical, mechanical or biomedical discipline.

+ Minimum of 2-3 years of biologic manufacturing process development; quality assurance experience a plus.

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

+ Experience with tech transfer, scale-up, BPR review, person in plant, process sciences.

+ Proficient with downstream operations/equipment including chromatography, TFF, VF, buffer prep.

+ 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 communicate clearly and professionally both in writing and verbally.


**_If you, or someone you know, would like to be considered please apply online today to discuss next steps._**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-01-14 Expires: 2022-02-14

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MSAT Engineer/ Medical Science Liaison (Upstream)

Kelly Services
Tustin, CA 92781

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