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10 days old

Staff Product Transfer Scientist

Kelly Services
Sunnyvale, CA 94086
**Kelly is actively recruiting for a Direct Hire Staff Product Transfer Scientist in the Greater San Jose area, CA.**


**Position Summary:** The Staff Product Transfer Scientist represents Assay Manufacturing Operations in cross-functional core teams for diagnostic assay development. The Staff Scientist will be a technical partner and subject matter expert to the R&D team throughout the life cycle of the new diagnostic assay products in ensuring manufacturability, troubleshooting, scale-up and testing strategy. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, Supply Chain and other functions within Client is expected.


**Essential Job Responsibilities:**


+ Actively participate in the development of new products as a representative of manufacturing operations to ensure compatibility with current and future manufacturing processes and capabilities.

+ Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products. Conduct design for manufacturability (DFM) review meetings routinely.

+ As appropriate, serve as a technical liaison and subject matter expert for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, control material, reagent formulation, manufacturing processes and product testing.

+ Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production:

+ production scale-up

+ process development/optimization

+ technology transfer

+ process validation

+ test method validation

+ SAP extension and costing

+ Develop and maintain production documentation including procedures, worksheets, and bills of materials.

+ Uses in-depth of manufacturing and assay knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation. Assists team members in troubleshooting.

+ Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.

+ Leads smaller teams of product transfer associates or functional teams in the execution of complex projects.

+ Actively consults with other manufacturing teams as an assay subject matter expert to improve products, processes or services.

+ Serves as a mentor to junior team members during project execution.

+ Leads smaller teams of product transfer associates or functional teams in the execution of complex projects.


**Minimum Requirements:**


+ Masters degree or Ph.D. in Life Sciences, Bioengineering or Engineering with 7 years of relevant experience or Bachelors degree with 15 years of relevant experience.

+ Ability to manage multiple projects simultaneously with short deadlines

+ Ability to communicate technical issues both verbally and in written form

+ Effective organization and planning skills

+ Excellent communication skills and the ability to develop working relationships with multiple departments

+ Proficiency in Molecular Biology techniques

+ Proficiency in qPCR


**Preferred Requirements:**


+ Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations.


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


\#TJP2021_SPEC


**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)
Posted: 2021-10-11 Expires: 2021-11-11

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Staff Product Transfer Scientist

Kelly Services
Sunnyvale, CA 94086

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