Manufacturing Associate at Crispr Therapeutics Inc in Framingham, Massachusetts

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals. 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 San Francisco, California, and business offices in London, United Kingdom.

Position Summary

Reporting to the Manufacturing Manager, the Manufacturing Associate will perform manufacturing activities associated with immuno-oncology GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of allogenic gene edited cell therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing aseptic cell culture within a GMP environment.

Responsibilities

• Perform clinical / commercial product manufacturing for a cell and gene therapy according to cGMP standards and SOPs.


• Perform aseptic cell culture, aseptic vial filling, visual inspection, cryopreservation, process media formulation, media component aliquoting and kitting.


• Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.


• Participates in technology transfer from Process Development to the Manufacturing group.


• Assists in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups.


• Ensures all materials and equipment are identified and available in time for manufacturing operations.


• Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.


• Executes standard work per manufacturing schedule


• Participate in Quality investigations and resolutions.


• Ensures cGMP compliance through consistent execution.


• Other duties and projects as assigned to meet departmental requirements.

Minimum Qualifications

• Certificate, associate's or bachelor's degree in biological sciences or related fields


• 3+ years of relevant Manufacturing experience or related fields (cell culture, support, media prep)


• Available to work a flexible schedule as needed.


• Ability to don cleanroom garments and work within a classified environment (Grade B and C)


• Knowledge of GMP and industry standards


• Fluency in Windows and Microsoft Office applications


• Attentive to detail and accuracy


• Ability to effectively communicate and collaborate with internal stakeholders is essential


• 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


• Ability to lift 40 pounds


• Ability to stand for 6 hours in a clean room environment


• Self-driven, independently motivated, data driven and excellent problem-solving ability

Preferred Qualifications

• Prior experience in cell or gene therapy manufacturing

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.

Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.

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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