Manufacturing Associate, LNP

CRISPR Therapeutics•Framingham, MA

9d•$35 - $42•Onsite

About The Position

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.

Requirements

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

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.