Data Review and Sample Management Coordinator

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 01/01/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases

Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

Job Summary

We are seeking a Data Review Coordinator in our Reference Sample Management Department to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases at CRISPR Therapeutics. The successful candidate will be responsible for managing the reference sample program. The position will interface with the within Technical Operations, Research, PD, CDMOs/CMOs and Quality to develop and own a robust reference sample program.  The ideal candidate has significant experience with analytical development, validation, tech transfer, comparability protocols, and reference sample inventory management.

Responsibilities

  • Maintain a strategic relationship with internal and external partners in the Manufacturing organization
  • Coordinate with other functions to assess the reference sample needs across multiple programs
  • Coordinate with PD and external CMOs to schedule manufacturing slots
  • Establish a reference sample inventory program
  • Support internal and external sites with acquisition and characterization of reference samples
  • Work with the Stability Group to establish stability protocols
  • Manage Data review and Data Management group and build a culture of data integrity
  • Build and manage a strong training curriculum for analysts
  • Perform Quality metrics review (QMR) and annual report reviews
  • Support Quality Systems by authoring laboratory investigations, deviations, CAPAs, and change controls
  • Develop and implement SOPs, protocols, and reports related to reference materials

 

Minimum Qualifications

  • Experience; MS with +2 yrs. experience; BS with +3 years of industrial experience
  • Strong experience in conducting Validation, tech transfer, comparability studies
  • Experience in participating in internal audits and regulatory inspections (FDA, MHRA, Canada HA etc.)
  • Experience in risk management process (CQA, FMEA), Lab investigations, OOS and Deviations is preferable
  • Highly skilled in statistical methods, statistical process control, sampling plans, and design of experiments
  • Experience with inventory management systems is desired.
  • Experience with preparing quality metrics reviews and annual review reports
  • Previous experience in implementing LIMS and other data management program is highly desirable.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion.
  • Self-driven, independently motivated, data driven and excellent problem-solving ability.
  • Ability to effectively communicate and collaborate with internal and external stakeholders is essential.

 

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

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.