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Director of Manufacturing IT

Company: CRISPR Therapeutics
Location: Framingham
Posted on: September 12, 2020

Job Description:

Company Overview

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 ?-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

This position is responsible for the oversight of all Manufacturing IT Systems at a new internal facility pertaining to the manufacture and disposition of clinical and commercial products. This position reports to the Corporate Head of IT and is a high visibility, high impact role.

Responsibilities

Lead and manage the continued deployments, maintenance and enhancements of all relevant integrated systems and the overall digitalization of CRISPR’s manufacturing site

Serve as the IT lead for all Site specific system related changes and enhancements

Interact with partners both internal and external to CRISPR regarding the Manufacturing IT Systems used at the site

Oversee the integration of BMS, MES and other process control systems such as Delta V

Implement computerized maintenance management systems such as Blue Mountain

Manage enterprise data historian systems such as OSI Pi

Manage the integration of commercial LIMS systems such as LabVantage

Adhere to all GMP policies and procedures as they relate to integrated systems

Partner with Quality Assurance (QA) to ensure that integrated systems are compliant

Education and Experience

Bachelor’s degree or above in an IT/Engineering discipline

10-15 years of technology experience, preferably in Life Sciences or Manufacturing within a regulated environment

Experience with ERP systems such as Oracle or SAP

Experience with Quality Management Systems such as Veeva QMS

Experience with Quality Document Systems such as Veeva QualityDocs

Experience with Supply Chain Management systems preferred

Excellent interpersonal and communication skills

Knowledge of Good Manufacturing Practices

Knowledge of Compliance and Validated Computerized Systems

Knowledge of EH&S

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.

The following questions are entirely optional. To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more .

Invitation for Job Applicants to Self-Identify as a U.S. Veteran

A “disabled veteran” is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or

a person who was discharged or released from active duty because of a service-connected disability.

A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE

I AM NOT A PROTECTED VETERAN

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Voluntary Self-Identification of Disability Form CC-305

OMB Control Number 1250-0005

Expires 5/31/2023

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

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Keywords: CRISPR Therapeutics, Framingham , Director of Manufacturing IT, Other , Framingham, Massachusetts

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