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23 days old

Senior Process Scientist

Kelly Services
Arcadia, CA 91007
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with industry leading employers. Today we are excited to be hiring a **_Senior Process Scientist_** for a cell and gene therapy company in Covina, CA. The **_Sr. Process Scientist_** will support upstream and downstream process development and tech transfer within cell and gene therapies including process design, scale-up, media prep, cryopreservation, process validation, and PPQ. The successful candidate will have extensive experience with developing cell and gene therapy processes utilizing QbD and DoE concepts and possess expertise in critical material and equipment knowledge to achieve an efficient, robust process development from Stage 1 to Stage 3 of product development. Additionally, this candidate will have demonstrated knowledge and experience in at-scale process optimization.


**Responsibilities:**


+ Assist to establish process capabilities to support process development of different cell and gene therapeutic modalities, using various starting materials

+ Review critical templates for sampling plans, tech transfer SOPs, gap and risk assessments, exceptional conditions process, process change controls, and other process-related protocols and technical reports

+ Serve as a technical SME and assist with Tech Transfer for unit operations such as cell selection, culture and cell modification, harvest, formulation fill/finish, media prep and drug product cryopreservation

+ Develop robust processes implementing QbD and DoE concepts, and closed system solutions for cell isolation, activation/stimulation, transduction / electroporation, cell expansion, and drug product formulation fill/finish

+ Evaluation of new equipment, supplies/materials and projects to implement and optimize processes

+ Performing cell processing runs and documenting in electronic lab notebook

+ Assisting with identifying, instituting, and refining TPP/QTPP, PQRAs, CQAs, CPPs, KPPs, and CMAs for cell and gene therapy processes throughout clinical phases of product development

+ Evaluate and integrate novel automated technology platforms to streamline scale-up and/or scale-out and optimize processes for manufacturing

+ Establish/nurture strong working relationships with both internal and external vendors, and partner organizations

+ Assist with process characterization efforts

+ Keep abreast on latest process technology platforms and analytical methods for process performance evaluations

+ Requirements:

+ Bachelor's degree in Biomedical/engineering or Life Science related discipline with 5 years experience or Master`s degree with 2-5 years experience

+ Minimum of 3 years of process development or manufacturing experience in cell and gene therapy field

+ Mastery of scientific and engineering principles

+ Practical experience in GMP operations

+ Direct experience with optimization and manufacturing of cell therapy processes

+ Direct experience with process design, optimization, validation, qualification, and verification experience are highly desirable


**_Apply today to start a conversation on Whats Next for your Career!_**


Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview


Additional questions may also be e-mailed to athena.parker@kellyscientific.com


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-12 Expires: 2022-10-13

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Senior Process Scientist

Kelly Services
Arcadia, CA 91007

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