Cell Manufacturing Associate I/II (iPSC)

United Therapeutics Corporation•Silver Spring, MD

6d•$30 - $36•Onsite

About The Position

The Cell Manufacturing Associate I/II supports the startup and operation of induced pluripotent stem cell (iPSC) manufacturing processes. The role contributes to establishing a robust manufacturing platform for high-quality cell therapy products and supports manufacturing operations and process implementation in a collaborative, GMP-regulated environment focused on scientific excellence, quality, and continuous improvement. The position is 100% onsite in Silver Spring, Maryland. The associate performs hands-on manufacturing operations in a phase-appropriate GMP environment, including iPSC expansion, differentiation, harvest, and cryopreservation. The role also supports equipment setup and operation, preparation of manufacturing materials and samples, cleanroom and equipment sanitation, production documentation, process troubleshooting, and compliance training. The position participates in a 24/7 on-call rotation to acknowledge manufacturing equipment alarms.

Requirements

For Associate I: Bachelor's degree in biology, cell and molecular biology, biomanufacturing, or a related field.
For Associate I: Hands-on experience operating cell manufacturing equipment, including automated and closed-system platforms such as biosafety cabinets, centrifuges, tube welders, and sealers.
For Associate II: Bachelor's degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field.
For Associate II: At least 2 years of relevant experience in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, regenerative medicine, or a related field.
For Associate II: At least 2 years of hands-on experience with multiple culture vessel types, including T-flasks, multi-well plates, Hyperflasks, CellSTACKs, and bioreactors.
Experience with aseptic technique, cleanroom practices, and contamination control.
Basic understanding of cell therapy techniques, including cell isolation, transduction, expansion, and differentiation.
Ability to accurately document work in batch records and logbooks and follow standard operating procedures.
Ability to work in a regulated cleanroom environment, including extended periods in full gowning.
Ability to learn new techniques quickly and contribute to process improvements.
Ability to work effectively in an ambiguous, fast-changing manufacturing startup environment and adapt to evolving processes, priorities, and requirements.
Ability to work a rotating schedule that includes weekends and holidays, as well as flexible hours and off-shift support for routine cell culture activities and unplanned manufacturing needs.
Ability to interpret data and perform basic mathematical calculations, such as dimensional analysis, molarity, seeding calculations, and serial dilutions.

Nice To Haves

At least 1 year of hands-on experience handling T-flasks, multi-well plates, and benchtop bioreactors.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).

Responsibilities

Perform iPSC expansion, differentiation, harvest, and cryopreservation using aseptic technique and good documentation practices.
Set up and operate cell manufacturing equipment, including bioreactors and equipment for flask coating and preparation.
Prepare raw materials, vessels, assemblies, media, tools, and samples.
Clean and sanitize the cleanroom environment and equipment.
Prepare samples for analytical testing and in-process checks.
Author and review production documentation, including SOPs and production records, and support updates based on process changes.
Complete good documentation practices for batch records and logbooks, and support document review and revision cycles.
Perform basic troubleshooting and assist with technical issues during manufacturing runs.
Maintain personal cGMP training to ensure compliance.
Participate in a 24/7 rotating on-call schedule to acknowledge manufacturing equipment alarms.
Perform other duties as required.