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29 days old

Process Development Scientist - Princeton, NJ

Kelly Services
Princeton, NJ 08544
Process Development Scientist _ Princeton, NJ



Kelly Services is currently seeking a Process Development Scientist for one of our top clients in Princeton, NJ to support a 12-month assignment.



**JOB SUMMARY** :



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.



**JOB RESPONSIBLITIES:**




+ Lead 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.).

+ Design and lead technology transfer activities for customers manufacturing process, conduct process development and/or process optimization activities in partnership with customers team.




+ Design and lead technology transfer activities and conduct process development/optimization with internal teams for new platforms, technologies and assay development activities

+ Design and lead (along with Operation Team) 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 customers 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.

+ Able to build and foster strong relationships with cross-functional teams within the Cell Therapy BU including Operations, Quality Control, Quality Assurance, Facilities & Engineering and Environmental Health and Safety.

+ Able to build strong relationships with customer liaisons

+ 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 travel to internal sites for training and customer sites for Technology Transfer activities. Travel up to 20%





**JOB REQUIREMENTS:**



Education




+ Bachelors degree in science or engineering required. Masters degree in science or engineering preferred.



Experience




+ 5-8 years of relevant experience in a related field or industry required

+ Experience in GMP environment preferred



Knowledge, Skills, Abilities




+ 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





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.





Why Kelly?




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*





Apply Today!



*Available for purchase and administered by a designated third-party vendor




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-02 Expires: 2020-11-02

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Process Development Scientist - Princeton, NJ

Kelly Services
Princeton, NJ 08544

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