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

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Job description

**Sr.Scientist, Process Development (Analytical Development) - Irvine, CA**

**Summary/Objective:** The Senior Scientist will support the Analytical Development group related to all viral vector testing activities/initiatives. He/she will manage testing and characterization of viral vector products as well as in process production and purification intermediates. The Sr. Scientist will ensure that the required assays related to identity, potency, purity, safety and stability are being developed, transferred and implemented. He/she will support the transfer of assays to Quality Control and ensure qualification and validation based on product/clinical trial phase. The Sr. Scientist will participate in testing activities related to new process scale-up, process optimization, technology transfer and process validation activities.

**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 testing challenges

+ Designs and Performs experiments at the bench and pilot scales, spanning all aspects of testing and characterization of viral vector products, intermediates, contaminants and residuals.

+ Interacts with other Process Development functions to provide the needed support for in-process testing related to viral vector and protein production and purification processes.

+ Develop state-of-the art assays and ensure all testing meets regulatory requirements for viral vectors and vaccines

+ 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

+ Utilizes design of experiments and statistical analysis of data

+ Will interface with client and must be articulate around the science and problem solving

+ Supervises a team of 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:**

+ PhD in Molecular Biology, chemistry, biochemistry, chemical/biochemical engineering or related disciplines

+ 5 years of technical experience in testing and characterization of viral vectors or large molecules.

+ Knowledge of regulatory requirements (national and international).

+ Managerial experience with proven capability as a successful leader.

+ Good business acumen and critical thinking.

+ Knowledge of process characterization and validation.

+ Experience with assay transfer to Quality Control.

+ Knowledge of cGMP's and 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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