- 186807 - Process Development Associate
- NJ-New Jersey
- Up to $25.00 DOE
- 12 mos
- Chipton-Ross is seeking a Process Development Associate for an opening in Princeton, NJ.
Our client is making a significant investment in the dynamic and rapidly growing Cell Therapy space. The candidate will be a part of a Cell Therapy Process Development team and will be responsible for highly specialized technical research and expert consultation including identifying, innovating and designing solutions for unique process development and manufacturing activities related to clinical materials. This position entails a deep understanding of current Good Manufacturing Practice (cGMP) manufacturing requirements and transitioning workflows from Process Development lab to GMP suite. These functions may include but are not limited to activities such as processing of blood related products, isolation and propagation of variety of human primary cells, preparation of cell culture media, culture and expansion of cells in closed automated systems.
Assist in development activities for new processes and procedures for first-in human clinical materials including design of process scale-up/scale-out, use of automation and closed systems (handling of bags and tubing, working with instruments such Sepax C-Pro, Elutra, Xuri, Wave, Lovo, Prodigy etc). Assist in technology transfer activities for customer’s manufacturing process, conduct process development and/or process optimization activities in partnership with customer’s team. Work with members of the Process Development and Operations team for transfer activities and assist in conducting process development/optimization with internal teams for new platforms, technologies and assay development activities. Provide assistance and input (along with Operation Team) for development/establishment runs to meet GMP requirements through successful process transfer. Work with internal MS&T partner to conduct thorough gap analysis and risks associated with customer’s manufacturing process and develop documents and plans to clearly communicate such gaps. Develop a strategy to overcome such gaps through process optimization activities. Host customers in order to showcase existing manufacturing platforms and discuss ideas for development of new platforms and workflows. Authoring and execution of work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Train and support other members of the Process Development Team. Act as On-The-Job-Trainer for a variety of job functions. Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. Able to work with cross-functional teams within the Cell Therapy BU including Operations, Quality Control, Quality Assurance, Facilities & Engineering and Environmental Health and Safety. Able to travel to internal client sites for training and customer sites for Technology Transfer activities. Travel up to 20%.
3-5 years of relevant experience in a related field or industry required. Experience in GMP environment preferred. Understanding ‘why’ and not just the ‘how’ of processes and practices. Knowledge of cGMP practices required. Knowledge and deep experience of aseptic techniques, cell culture, workflows for manufacturing Cell Therapy products (CAR T, MSCs, iPS cells etc). Knowledge and deep experience in cryopreservation and fill & finish activities for final Cell Therapy product required. Confidence and experience with closed and automated systems specific to Cell Therapy manufacturing required. Mechanical Skills/ Analytical Skills/Method Automation. MS Office. Strong math skills. Strong prioritization skills. Extremely detail oriented. Results driven. Able to read, write, and communicate in English. Able to understand and carry out instructions. Reliable. Strong communication (written and verbal). Effectively multi-task. Able to work in an environment of change. Able to work independently and as part of a team. Able to recognize problems developing, not just occurring.
Accredited Bachelor’s degree in science or engineering required.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.