Scientific - Bio Analytical Scientist

Job Description: Job Title: Bio Analytical Scientist
Location: Seattle WA*Onsite
Top Skills:
Proven experience with physicochemical analytical techniques such as chromatography electrophoresis/CE etc.
experience working with Waters UPLC system and Empower software
Methods: SECU/HPLC SECMALS IEX RPLC Affinity CE: PA800 (SCIEX) CESDS CZE cIEF
Experience with proteins characterization preferred

Position Summary:
Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic selfdriven Scientist to join its Residual Ancillary Materials and Protein Characterization analytical development team. The Scientist will lead development of analytical methods to characterize processrelated impurities and assess impurity clearance in autologous and allogenic cell therapies. The Scientist will be responsible for developing impactful methods including QC methods for lot release testing as well as characterization methods that support process development and comparability assessments. These methods will be used to further our understanding of cell therapies and support development of manufacturing processes and/or QC release of the drug product. The successful candidate must have extensive handson experience in assay development and possess excellent communication skills in order to work on projects requiring close collaboration with other groups such as discovery research product sciences process development and QC. Additionally the Scientist will interface with external vendors (e.g. CMOs) for the successful management of any transferred analytical methods. The Scientist should be passionate about developing novel medicines thrive in an intellectually challenging environment and enjoy collaborating with a team of likeminded Scientists.

**Roles and Responsibilities**
Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding.
Independently develop and execute bioanalytical or molecular assays (e.g. chromatography electrophoresis/CE assays)
Identify issues lead troubleshooting experiments and determine solutions with minimal to no guidance
Train users on method execution data analyses and proper use of instrumentation
Lead qualification and transfer of analytical methods to external stakeholders
Routinely present work at team technical team and department meetings
Maintain meticulous laboratory notebooks
Analyzing interpreting and presenting data to internal and external stakeholders (Power Point Presentations)
Author review and approve technical documents including methods protocols reports and SOPs
Deliver lifecyclemanaged analytical methods for multiple programs with an understanding of ICH/FDA/EMEA best practices and current thinking.
Facilitate smooth operation of the laboratory including ordering assisting in the cryopreservation of cellular material sample management etc.

**Qualifications & Experience**
Education:
BS MS or PhD in Molecular Biology Analytical Biochemistry Immunology Microbiology Cell Biology or related field. PhD with 03 years or MS with 3 years or BS with 7 years of relevant industry experience.
Basic Qualifications
Proven experience with physicochemical analytical techniques such as chromatography electrophoresis/CE etc.
experience working with Waters UPLC system and Empower software
Methods: SECU/HPLC SECMALS IEX RPLC Affinity CE: PA800 (SCIEX) CESDS CZE cIEF
Experience with proteins characterization preferred
Strong problemsolving ability to troubleshoot complex technical and scientific problems.
Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g. CMOs).
Strong attention to detail.
Outstanding written and oral communication skills.
Work effectively in a collaborative team setting.
Ability to work in a rapidly changing environment with frequent changes in priorities.

Preferred Qualifications
Knowledge of immunology and T cell biology as applied to the cell therapy field
Knowledge or experience with vector and gene editing analytics (AAV CRISPR etc)
Experience with molecular techniques (e.g. qPCR RTqPCR and/or ddPCR).
Experience with data analysis and interpretation using software (e.g. Softmax Pro Gen5 Excel Prism Graphpad).
Familiarity with statistical analysis and design on experiments (DoE) using JMP software.
Track record of successful transfer and management of analytical methods
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Ph: (908)Ext: 9084