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

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Job description

**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 cGMP's, 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 _**

**_\#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.

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