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Scientist / Sr. Scientist Analytical Process Development - 10212

Company: Simply Biotech
Location: Tustin
Posted on: June 26, 2019

Job Description:

Scientist / Sr. Scientist Analytical Process Development - Simply BiotechOverviewAre you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.Immediate opening for a Scientist / Sr. Scientist Analytical Process Development in Tustin, CA who possesses:PhD in relevant scientific discipline with 2+ years' industry experience (5 years for Sr. Scientist) OR MS with 5+ years' industry (10 years for Sr. Scientist) OR BS with 8+ years' industry (15 years for Sr. Scientist)Biopharmaceutical experience with mammalian cell culture REQUIREDExperience developing protein analytical methods within a process development department (not QC)Leading method development, optimization and feasibility evaluations for key protein bioanalytical assays for in-process testing (PD support) and release including:HPLC (SEC, CEX, HILIC, RP)Capillary electrophoresis (CE-SDS, cIEF)Immunoassays (ELISA)qPCRCell-based potencyLeading method transfer to QC for release assaysLeading design and oversight of product characterization workflow for reference material / comparability studies including:HPLC (SEC, CEX, HILIC, RP)Capillary electrophoresis (CE-SDS, cIEF)Immunoassays (ELISA)Cell-based potencyGlycan analysisNo Small Molecules, peptides, vaccines, or other non-protein experienceEmail resumes to dgranholm@simplybiotech.com or call 858.239.2849Full DescriptionThe selected candidate will further possess:Experience in analytical method development for release, stability, in-process testing, and product characterization of glycoproteins derived from mammalian cell culture processes.Proficiency with the following techniques is necessary and/or desired: (U)HPLC, capillary electrophoresis, immunoassays, enzyme activity assays, qPCR, spectrophotometry, mass spectrometry.A background in Chemistry, Analytical Chemistry, Biochemistry, or Biology is preferred.Supervision experience is desired.Experience with bioanalytical method transfer for drug substance and drug product release and stability testing from other labs and/or into QC is desired.Experience with applying the principles and techniques of Analytical Chemistry is required.Knowledge of GMPs is desired.The Selected Candidate Will Be Responsible For The FollowingLead phase-appropriate analytical method development and transfer to QC laboratories for biologics drug substance/drug product release and stability testing as well as development of in-process and product characterization methods.Lead biologics method development and testing support for process development.Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports.Serve as an analytical representative on client-facing project teams.Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments and clients. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.Lead, motivate, and develop the people in their group.Routinely make decisions affecting direction of project to ensure project timelines are met.Direct research associates or members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.Participate in client visits presenting on analytical skills and experiences of the team, defining scope of works and timelines as well as estimated stage costs including raw materials.Responsible for conducting scientific research for the development of analytical methods for biologics.Applies the principles and techniques of Analytical Chemistry to biologics development.Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company and clients' interests.Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.May contribute to scientific literature and conferences or regulatory filings.Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.Primary project contact with a client for the analytical method development scope. Articulate around the science and problem solving as well as timeline and costs.Develops estimates of timelines, budgets and statements of work to support client requests.Develops capital proposals when lab equipment needs to be purchased, upgraded or replaced.This position may supervise 2 - 4 Research Associates. For immediate and confidential consideration, please email your resume to dgranholm@simplybiotech.com or call 858.239.2849More information can be found at www.simplybiotech.comSimply Biotech specializes in recruiting exclusively for the biotech community.by Jobble

Keywords: Simply Biotech, Simi Valley , Scientist / Sr. Scientist Analytical Process Development - 10212, Other , Tustin, California

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