Manufacturing Associate, LNP

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
• Aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting
• Transfer raw material inside cleanroom suite using sanitizing reagents or equipment
• Participate 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
• Ensure 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

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
• Ability to work effectively in a collaborative team environment
• 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

Qualifications

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

Skills

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.

Benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

Pay

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

Schedule

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