Company: Netpace, Inc.
Location: San Mateo
Posted on: May 3, 2021
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).
Support activities related to the transfer and validation of
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
Participate in generating training module and instruction led
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
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
Ability to think critically and demonstrate troubleshooting/problem
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
In term of degrees and numbers of years, it's not so critical as
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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