Senior Cell Manufacturing Associate (iPSC)

United Therapeutics Corporation•Silver Spring, MD

7d•$36 - $43•Onsite

About The Position

Join the Cell Manufacturing team as a Senior Cell Manufacturing Associate and help start up and operate 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 brings technical expertise to daily manufacturing operations and serves as a go-to resource for technology transfer, troubleshooting, documentation, training, and mentoring. 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 also supports production documentation, investigations, process improvements, inventory and procurement activities, and a 24/7 on-call rotation to acknowledge manufacturing equipment alarms. The position is 100% onsite in Silver Spring, Maryland, and requires rotating schedule coverage that includes weekends and holidays, flexible hours, and off-shift support as manufacturing needs arise.

Requirements

Bachelor’s degree in biology, cell and molecular biology, biomanufacturing, or a related field.
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 for 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 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 and unplanned manufacturing needs.
Ability to interpret data and perform basic mathematical calculations, such as 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.

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 while maintaining aseptic technique and good documentation practices.
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.
Perform moderately complex troubleshooting and assist with technical issues, including root cause analysis.
Document work 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, including SOPs and production records, and support updates based on process changes.
Maintain personal cGMP training and assist in 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 on-call rotation to acknowledge manufacturing equipment alarms.
Perform other duties as required.