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22 days old

Principal Scientist Process Development

Kelly Services
Arcadia, CA 91007
Kelly Science & Clinical is excited to be hiring a **_Principal Scientist_** for a leading Cell and Gene Therapy Manufacturing company in Covina, CA! The Principal Scientist will support upstream and downstream process development and tech transfer within cell and gene therapies. The Principal Scientist will be responsible for 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, a great[1]fit candidate has demonstrated knowledge and experience in at-scale process optimization


**Job Duties Include:**


+ Establish process capabilities to support process development of different cell and gene therapeutic modalities

+ Establish 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 Tech Transfer lead for unit operations such as cell selection, culture and cell modification, harvest, formulation fill/finish, media prep, in-line purification of drug substance, and drug product cryopreservation

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

+ 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

+ Capable of 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

+ Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and others.

+ Prepare and present to leadership, external clients, and stakeholders on process development strategy, latest data and conclusions, plans and roadmap to meet clients and companies development goals.

+ Builds a strong scientific and technical laboratory team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews.

+ Support technology transfer of products and processes to MSAT/ into the cGMP facility and serve as a key SME with external laboratory organizations and key clients as well as material/component and equipment/instrument vendors.

+ Investigate and resolve problems, identify root cause, and propose laboratory operation improvements through clear communication to senior management.

+ Interact with outside vendors and senior management.

+ Participate in multi-functional project teams, as necessary.

+ Take corrective action to bring about required changes using approved change control procedure


**Requirements:**


+ Masters/Ph. D degree in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences with minimum of 8 years of experience in biotechnology industry with at least 3 years of process development in cell & gene therapy

+ Minimum of 5 year experience in managing a technical laboratory team

+ 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

+ Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, electroporation platforms, gene editing approaches, and cell and gene therapy modalities

+ Ability to function efficiently and contribute as part of a team, and contribute to team-based decisions in a fast-paced environment

+ Familiar with data analytics software such as JMP and/or Minitab software to map out


**_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.


\#P2


**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.

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Posted: 2022-09-12 Expires: 2022-10-13

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Principal Scientist Process Development

Kelly Services
Arcadia, CA 91007

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