Kelly Services Process Development Scientist, San Diego, CA in San Diego, California

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Process Development Scientist, San Diego, CA

Primary Duties & Responsibilities

  • Independently design and conduct experiments supporting the development and implementation of a closed system, scale-up manufacturing process for hMSCs.

  • Responsible for utilizing, where applicable, Quality by Design (QbD) processes, including risk assessment and design of experiment (DOE), to ensure robust development and documentation of processes.

  • Design and execute formal process characterization studies and perform statistical analyses to determine overall design space.

  • Execution of studies includes media preparation, cell seeding, media change and harvest of hMSCs.

  • Support on an as needed basis additional Process Development projects, such as identification of second source media components, optimization of serum-free media and culture conditions for hMSCs and optimization of the hNSC manufacturing process.

  • Serve as project lead to establish project plans and schedules and accomplishing set milestones.

  • Appropriately document experimental procedures and results according to established guidelines.

  • Draft and/or revise standard operating procedures (SOPs), forms, policies, batch records, proposals, reports and investigations.

  • Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.

  • Participate in tech transfer activities related to new or enhanced processes to the GMP manufacturing facility.

  • Interact with the QC department to submit sample requests.

  • Interact with vendors to provide equipment, materials and best practices to the process.

  • Manage laboratory supply inventory, including ordering and restocking.

  • Perform routine and advanced duties required to clean, maintain and operate equipment.

  • Adhere to all EH&S policies, procedures and guidelines.

Skills and Experience

  • Understanding of GMP biologics manufacturing is required with an in-depth knowledge in upstream techniques and technologies.

  • Expertise in adherent stem or progenitor cell culture required.

  • Hands on experience with closed culture systems, and familiarity with the commercially available 2D and 3D cell expansion platforms.

  • Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.

  • A drive for continuous improvement.

  • Effective and professional communication skills, written and oral, and aptitude for problem solving.

  • Excellent computer skills, proficient with Microsoft Word, Excel, PowerPoint and Visio, and working knowledge of JMP or equivalent statistical software.

  • Good interpersonal skills and customer service skills, and ability to work effectively in an independent or team environment.

  • Must have the following personal attributes: personal accountability, integrity and trust, work ethic, sound judgment, intellectual, honesty, pragmatism, eagerness to learn and continuously improve and a dedication to quality.

Education

  • Masters in biological sciences, chemical engineering, biochemistry or related discipline

  • M.S. with at least 5 years of experience in process development, biologics or related field.

Live Chat with a Recruiter!! https://flashrecruit.com/jobs/300613

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.