Quality Control Analyst (Multiple Openings)

CRISPR Therapeutics•Framingham, MA

1d•Onsite

About The Position

CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals . Our QC team is looking for enthusiastic individuals to work full time at our state-of-the-art manufacturing facility in Framingham, MA. QC Analyst is a lab based role that is a valuable member of the Quality Control team that will perform in-process, final product, raw material, stability, environmental monitoring, and microbiological testing of novel drug therapies. The successful candidate will perform various biochemical, biophysical, molecular biology, chromatographic, environmental and compendial tests in a GMP environment. In addition, the QC Analyst will support analytical method implementation, transfer and validation projects to support business and clinical needs.

Requirements

Minimum of bachelor’s degree in a relevant scientific area with 3-5 years of relevant industry experience.
Hands-on experience with at least one of the following techniques: flow cytometry, PCR, UPLC Chromatography.
Excellent communication skills, technical writing, and detail oriented.
Good at managing time and evolving priorities in a flexible manner in dynamic environment.

Nice To Haves

Experience with cell culture, aseptic techniques, raw material testing, and/or chromatography preferred.

Responsibilities

Support the implementation and validation of analytical methods to the Framingham facility.
Performs routine in-process, final release, stability, raw material, environmental monitoring, and microbiological testing of CRISPR based products.
Write and/or revise SOPs, test methods, protocols, and reports.
Support QC investigations, OOS, deviations, CAPA implementation, and change controls.
Utilize Laboratory Information Management System to complete the data packets for review by senior members.
Perform other related duties based on business needs.