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18 days old

Senior Quality Control Analytical Scientist

Kelly Services
Palo Alto, CA 94301
Senior Quality Control Analytical Scientist, Palo Alto, CA



Direct Hire opportunity



Duties include:

The scientist will perform, direct and oversee the creation of test methods to support initiated innovative cell and gene therapies in close collaboration with PIs and SMEs.0

The scientist will be responsible for assay qualification and validation in a phase appropriate manner according to ICH and FDA guidelines by authoring protocols, reports, and investigations Assay platforms include qPCR, multi-color flow cytometry, qPCR, cell counting and cell based assays.

Lead or support cGMP investigation and generating corrective action plan for out-of-specification and deviations.

Write, review and edit accurate cGMP documents, including SOP, Test Procedures, Sampling Plan, Certificate of Analysis and Qualification/Validation Protocols

Planning and implementing critical analytical assessment of quality attributes to support the Analytical CMC development by closely collaboration with Process Development & Manufacturing, Regulatory Affair, and Quality Assurance

Oversee and support product specific QC operation is performed in consistent to sampling plan and manufacturing schedules including the operational assignments to individual QC associates for a variety of in process, drug substance, and drug product testing, sample shipments, data management and reporting data to stakeholders in a comprehensive manner.

Act as or collaborate with SME to ensure the cGMP compliance of facility and environment for clinical production of products at different phases.

Direct selection criteria and justification for QC raw materials;

Work with a cross-functional team as Liaison to ensure timely and comprehensive communication. .

* - Other duties may also be assigned





DESIRED QUALIFICATIONS:


Masters degree or higher in relevant scientific disciplines with post-graduate work experience preferred relevant scientific field may include Immunology, iPSC, stem cell biology, etc.

Knowledge and proficiency in cell based assay development, qualification and technology transfer

Proficiency of Multi-Color Flow Cytometry, qPCR and/or Immunoassays

Willing to learn and ability to effectively work in fast pace environment with cross functional groups


EDUCATION & EXPERIENCE (REQUIRED):


Bachelors degree and eight years experience or advanced degree and five years experience in relevant scientific relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, and Engineering).


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):


Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity

Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.

Expert knowledge and understanding of cGMP requirements.

Extensive experience in QC innovation and analytical methods and validation tests development.

Experience with technology transfer methods.

Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.

Experience leading and/or managing technical professionals.

Demonstrated resolution of complex issues in creative and effective ways

Excellent organizational skills and attention to detail.






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-27 Expires: 2019-12-28

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Senior Quality Control Analytical Scientist

Kelly Services
Palo Alto, CA 94301

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