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Company: Netpace, Inc.
Location: San Mateo
Posted on: May 3, 2021

Job Description:

Seeking a highly motivated individual to join us as a QC Analytical Specialist II to perform Analytical testing in our new research and clinical production facility located in Gaithersburg, Maryland. This facility will focus on the new challenging field of fully personalized T cell neoantigen reactive therapy for solid tumors using individual patient neoantigen TCRs.
The Specialist II within the QC group will have an overall responsibility, among others, of providing technical expertise for the execution of analytical test methods, supporting method transfer, promoting a culture of quality and compliance and assisting in improving quality metrics within QC.
We're seeking candidates with team-player mindset, willingness to meet goals through set timelines, and experience in 1) cell therapy, 2) molecular biology assays (qPCR, ddPCR, ELISA), and 3) cell culture of primary cells, human preferably, and 4) bioassays (cytokine release, cytotoxicity).
Key Responsibilities
Support activities related to the transfer and validation of analytical methods
Assist with deviation, investigation, CAPA and change control activities at Kite pharma and contract labs, as needed
Support inspection activities
Develop, revise and review SOPs, protocols and technical reports
Participate in generating training module and instruction led training material
Responsible for generating trending charts for monitoring method performance, product quality, invalid rate and/or stability

Master's with 5+ years, or Bachelor's with 8+ years of experience. GMP environment experience preferred.
Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, Real Time PCR (end-point, qPCR and ddPCR), ELISA (co-culture of effector and target cells), Cell Viability measurement, etc. FACS: Ability to design or qualify panels.
Experience in performing analytical method validation and supporting method transfer activities
Familiarity with automated instruments such as QiaCube, QiAgility, QiaSymphony and King Fisher is a plus. Familiar with FDA, ICH and GMP guidelines.
Ability to think critically and demonstrate troubleshooting/problem solving skills
Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
Excellent skills in Microsoft Office, data analysis software, and other related applications
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
In term of degrees and numbers of years, it's not so critical as written.
I'd like to focus on a candidate with some industry experience, fewer than 3-5 years.
Cell therapy experience is very preferable as opposed to antibody or small molecule experience.
This aligns better with (Kite) our scope of work and products.

Keywords: Netpace, Inc., San Mateo , Scientist, Other , San Mateo, California

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