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13 days old

Sr. Scientist, Process Development (Downstream) - Irvine, CA

Kelly Services
Tustin, CA 92781
**Sr. Scientist, Process Development (Downstream) - Irvine, CA**


**Summary/Objective:** The Senior Scientist will be responsible for complex programs related to all aspects of viral vector purification, generating bulk drug substance and drug product. He/she will support the group regarding downstream activities/initiatives.


**Essential Functions:** (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)


+ Undertakes complex and multi-faceted client and innovation programs.

+ Applies established platform approaches and utilize problem-solving skills to rapidly solve day to day experimental challenges. Provides support to the team regarding downstream activities.

+ Performs experiments at the bench and pilot scales, spanning the end- to end downstream drug substance/ drug product processes

+ Applies fundamental scientific and engineering principles to purification processes in order to support process development and process characterization, evaluate process improvements and resolve potential processing issues

+ Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings

+ Participates in cross-functional teams and interact with representatives from Process Development, Project Management, Manufacturing, and Quality to arrive at and implement viable / practical solutions to support clinical/commercial manufacturing

+ Provides scientific technical support for technology transfer of processes to manufacturing

+ Utilizes out-of-the-box thinking to contribute to technology development

+ Proficient with design of experiments and statistical analysis of data

+ Primary project contact with a client and must be articulate around the science and problem solving

+ Supervises a team of junior scientists and research associates

+ Manage timelines and coordinate resources with function heads to ensure project deliverables are achieved

+ Perform other duties as assigned


**Required Education and Experience:**


+ MS or PhD (preferred) in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines

+ 5 years of in-depth technical experience in purification process development for viral vectors and/or large molecules from mammalian and insect cells.

+ Knowledge and experiences in purification process engineering and process scale-up/scale-down design is essential.

+ Leadership experience as a successful leader in a strategic multi-functional environment.

+ Strong business acumen and critical thinking.

+ Experience in process characterization and validation.

+ Hands-on experiences with technology transfer of manufacturing process.

+ Knowledge of cGMPs, regulatory guidelines, validation practices, and other relevant regulatory requirements.

+ Excellent interpersonal communication and presentation skills


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**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** **** **?**


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/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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-11-24 Expires: 2021-12-25

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Sr. Scientist, Process Development (Downstream) - Irvine, CA

Kelly Services
Tustin, CA 92781

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