Senior QC Analyst, Flow Cytometry
Company: CRISPR Therapeutics
Location: Oklahoma City
Posted on: January 25, 2023
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Job Description:
Company Overview
CRISPR Therapeutics is a leading gene editing company focused on
developing transformative gene-based medicines for serious diseases
using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a
revolutionary gene editing technology that allows for precise,
directed changes to genomic DNA. CRISPR Therapeutics has
established a portfolio of therapeutic programs across a broad
range of disease areas including hemoglobinopathies, oncology,
regenerative medicine and rare diseases. To accelerate and expand
its efforts, CRISPR Therapeutics has established strategic
partnerships with leading companies including Bayer, Vertex
Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is
headquartered in Zug, Switzerland, with its wholly-owned U.S.
subsidiary, CRISPR Therapeutics, Inc., and R&D operations in
Boston, Massachusetts and San Francisco, California, and business
offices in London, United Kingdom.
Position Summary
Our QC team is looking for an enthusiastic individual to work at
our state-of-the-art manufacturing facility in Framingham, MA. The
Senior QC Analyst is a valuable member of the Quality
Control-Bioanalytical team that will coordinate and perform
in-process and final product testing of novel cell-based drug
therapies and AAV products. The successful candidate will perform
flow cytometry assays as well as various biochemical, biophysical,
molecular biology, and compendial tests in a GMP environment. In
addition, the QC Analyst will lead analytical method transfer and
validation projects. The QC Analyst-Flow Cytometry reports to the
QC Bioanalytical Sr. Manager.
Responsibilities
Support the transfer and validation of analytical methods to the
Framingham facility.
Performs routine in-process and final release testing of cell
therapies and AAV products.
Conduct raw material inspection and release per approved SOPs.
Assemble raw material data packages for release.
Complete and compiles all documentation and perform data review for
compliance and product release.
Assist with the data review for compliance and product release, and
generation of product COAs.
Author, review and approve SOPs, protocols, and reports.
Lead and/or support QC investigations, OOS, deviations, and CAPA
implementation.
Perform maintenance of QC equipment.
Assists in the implementation of the Laboratory Information
Management System.
Contribute to establish a reference standard program and sample
management system.
Perform other related duties based on business needs.
Minimum Qualifications
Minimum of bachelor's degree in biochemistry or related scientific
field.
Minimum of two years of experience in flow cytometry, preferable in
a QC environment.
Previous experience with multi-color flow cytometry, and other
analytical methods such as PCR, ELISA, Western blot, and compendial
methods.
Excellent communication skills, technical writing, and detail
oriented.
Good at managing time and priorities.
Preferred Qualifications
Experience with cell culture, aseptic techniques, and raw material
qualification, preferred.
Direct experience with analytical method validations and/or
transfers, preferred.
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Delivering progress toward our mission. Sense
of urgency in solving problems.
Entrepreneurial Spirit - Proactive. Ownership mindset.
CRISPR Therapeutics, Inc. is committed to equal employment
opportunity and non-discrimination for all employees and qualified
applicants without regard to a person's race, color, gender, age,
religion, national origin, ancestry, disability, veteran status,
genetic information, sexual orientation or any characteristic
protected under applicable law.
To view our Privacy Statement, please click the following link:
http://www.crisprtx.com/about-us/privacy-policy
Keywords: CRISPR Therapeutics, Oklahoma City , Senior QC Analyst, Flow Cytometry, Professions , Oklahoma City, Oklahoma
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