Cell Therapy Process Development Scientist (Autologous)

Our large pharmaceutical clients is seeking a Scientist to join their growing Process Development team within the Cell Therapy Development organization in Spring House, PA. This person will be focused on CAR-T cell manufacturing and will spend about 80% of their time in the lab setting up and running automation instruments for T cell manufacturing (primarily Prodigy), doing manipulation with cells, sampling, and making sure equipment is running properly. They will primarily be focused on process development in Car-T and its transition to manufacturing. In this role, the successful candidate will be involved in process design, unit operation development, and parameter optimization studies resulting in the development of new production processes. Other responsibilities include:

• Design and execute process development studies using sound scientific and engineering principles to develop and improve unit operations used for production of autologous T-cell therapies,
• Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product.
• Lead/contribute to the design and execution of phase-appropriate process development study plans, identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study.
• Investigate improvements to current processes used for T-cell selection, activation, transduction and expansion together with their impact on critical quality attributes.
• Author reports detailing experimental work and summarizing results, protocols, technical reports and SOPs.
• Support technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing

Qualifications:

• Minimum of a Bachelor’s Degree in a related field of study
• Minimum of 2 years of process development for autologous cell therapy or CAR-T manufacturing
• Hands on experience with CliniMACs Prodigy instrument for T-cell manufacturing is preferred

Salary: $90,000-$105,000 (flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO: 16 PTO Days & Paid Holidays

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.