Manufacturing Associate, LNP

Position Summary:
- Manufacturing Associate performing LNP GMP manufacturing in a state-of-the-art facility in Framingham, MA (33 New York Ave).
- Manufacture LNP therapies for clinical studies and as a commercial product; communicate across multiple departments for daily execution.

Responsibilities:
- Perform clinical/commercial manufacturing for LNP therapies per cGMP standards and SOPs (Lipid and RNA Prep, T-Mix, and TFF operations).
- Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
- Transfer raw materials inside cleanroom suite using sanitizing reagents/equipment.
- Participate in technology transfer from Process Development to Manufacturing.
- Assist in life cycle development of manufacturing SOPs with PD/MSAT and Quality Systems.
- Ensure materials and equipment are identified and available on time for manufacturing operations.
- Execute standard work per manufacturing schedule.
- Participate in Quality investigations and resolution.
- Ensure cGMP compliance through consistent execution.
- Other duties/projects as assigned.

Minimum Qualifications:
- Certificate/associate’s degree or higher in biological sciences (or related) plus 2–5 years relevant Manufacturing experience.
- Flexible schedule as needed.
- Ability to don cleanroom garments and work in Grade B/C classified environments.
- Knowledge of GMP and industry standards.
- Windows and Microsoft Office fluency.
- Attentive to detail and accuracy.
- Effective communication and collaboration with internal stakeholders.
- Ability to work in a collaborative team environment 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, excellent problem-solving ability.

Preferred Qualifications:
- T-Mix and TFF experience.

Compensation/Benefits (as stated):
- Base pay range: $35.00–$42.00 per hour + bonus, equity and benefits.