Senior Quality Control Analyst, Flow Cytometry
Company: CRISPR Therapeutics
Posted on: August 2, 2022
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
collaborations 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 based
in Boston, Massachusetts, and business offices in San Francisco,
California and London, United Kingdom.
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.
- 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
- 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
- Perform maintenance of QC equipment.
- Assists in the implementation of the Laboratory Information
- Contribute to establish a reference standard program and sample
- Perform other related duties based on business needs.
- Minimum of bachelor's degree in biochemistry or related
- 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
- Experience with cell culture, aseptic techniques and raw
material qualification, preferred.
- Direct experience with analytical method validations and/or
- Excellent communication skills, technical writing, and detail
- Good at managing time and priorities.
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.
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Keywords: CRISPR Therapeutics, Framingham , Senior Quality Control Analyst, Flow Cytometry, Professions , Framingham, Massachusetts
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