Manufacturing Associate, LNP

Manufacturing Associate

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 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.

Position Summary

Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP 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 LNP 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 formulated LNP Manufacturing within a GMP environment.

Responsibilities

• Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
• Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
• Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.
• Participates in technology transfer from Process Development to the Manufacturing group.
• Assist 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.
• Execute standard work per manufacturing schedule
• Participate in Quality investigations and resolutions.
• Ensure cGMP compliance through consistent execution.
• Other duties and projects as assigned to meet departmental requirements.

Minimum Qualifications

• Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
• 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
• T-Mix and TFF experience preferred
• 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

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.

Manufacturing Associate: Base pay range of $35.00 per hour to $42.00 per hour + bonus, equity and benefits.

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.