Senior Cell Manufacturing Associate (iPSC)

United Therapeutics•Silver Spring, MD

6d•Onsite

About The Position

Join United Therapeutics’ Cell Manufacturing team to support the startup and operation of induced pluripotent stem cell (iPSC) manufacturing. As part of the Differentiation or Reprogramming team, this hands-on role executes end-to-end cell manufacturing processes in a regulated environment and helps establish the processes, procedures, and capabilities needed for production. The associate provides technical expertise in daily manufacturing operations and serves as a resource for technology transfer, troubleshooting, documentation, and the training and mentoring of colleagues. The role performs manufacturing in a phase-appropriate GMP environment, including equipment setup and operation, iPSC culture and directed differentiation, harvest and cryopreservation, material preparation, and in-process testing. It requires aseptic technique, good documentation practices, support for investigations and process improvements, and participation in a rotating on-call schedule for manufacturing equipment alarms. The position is 100% onsite at the Silver Spring, Maryland office and requires a rotating schedule that includes weekends and holidays, as well as flexible hours and off-shift support when needed.

Requirements

Bachelor’s degree in biology, cell and molecular biology, biomanufacturing, or a related field.
At least 4 years of hands-on experience with multiple culture vessel types, including T-flasks, multi-well plates, Hyperflasks, CellSTACKs, and bioreactors.
Hands-on experience operating cell manufacturing equipment, including automated and closed-system processing platforms, cell separation and culture systems, and standard aseptic processing equipment such as biosafety cabinets, centrifuges, tube welders, and sealers.
Experience with aseptic technique in open-vessel and closed systems, cleanroom practices, and contamination control.
Understanding of basic cell therapy techniques, including cell isolation, transduction, expansion, and differentiation in 2D and 3D formats.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).
Ability to document work accurately in batch records and logbooks and follow standard operating procedures.
Ability to work in a regulated cleanroom environment, including extended periods in full gowning.
Capacity 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 for routine cell culture activities, as well as flexible hours and off-shift support for unplanned manufacturing needs.
Ability to interpret data and perform basic mathematical calculations, including dimensional analysis, molarity, seeding calculations, and dilutions.

Nice To Haves

Hands-on experience with stem cell differentiation, including iPSCs.
Basic understanding of quality control and in-process checks, such as viability, flow cytometry, qPCR, and endotoxin testing.

Responsibilities

Perform hands-on manufacturing operations in a phase-appropriate GMP environment, including equipment setup and operation, iPSC culture and directed differentiation, harvest and cryopreservation, material preparation, and in-process testing.
Set up and operate cell manufacturing equipment used for cell production.
Perform cell manufacturing processes such as cell culture and expansion according to established procedures, identifying opportunities for refinement.
Prepare raw materials, vessels, assemblies, media, tools, and samples.
Serve as a go-to operations expert and often act as a team leader, coordinating and leading the work of others.
Clean and sanitize the cleanroom environment and equipment.
Set up and run analytical tests and in-process checks to confirm compliance with quality standards, and escalate deviations appropriately.
Troubleshoot moderately complex technical issues, including performing root cause analysis.
Maintain good documentation practices in batch records and logbooks, and support document review and revision cycles.
Initiate and support investigations into process deviations, equipment issues, and operational events.
Author and review production documentation, such as SOPs and production records, and support updates based on process changes.
Maintain personal cGMP training and assist with training and mentoring junior team members.
Conduct routine inventory of production raw materials and consumables and assist with procurement activities.
Participate in a 24/7 rotating on-call schedule to acknowledge manufacturing equipment alarms.
Perform other duties as required.