Senior Scientist, Analytical Development - South San Francisco, CA | Biospace
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Senior Scientist, Analytical Development

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
6/26/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Development, Senior Scientist,

Job Description


Portola Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic disorders and inflammation for patients who currently have limited or no approved treatment options. Portola’s goal is to build an enduring biopharmaceutical company with a foundation of products and product candidates that significantly advance patient care in the areas of thrombosis, other hematologic disorders and inflammation. Portola is headquartered in South San Francisco, California.

The Senior Scientist, Analytical Development will work in a biopharmaceutical analytical development group responsible for analytical method development, method qualification/validation and QC transfer of active pharmaceutical ingredients( API) and drug products throughout the development pipeline. Development of assays used to characterize, establish, and monitor both the purity and strength of drug substances and products analytical method development/optimization and assay transfer to QC and/or contract testing laboratories is a core responsibility. Experience with various analytical techniques, such as HPLC, CE, SDS-PAGE, Western blot, , UV/Vis and Fluorescence spectroscopy, ELISA, cell-based and binding assays is a plus. A significant part of job responsibilities will entail familiarity with chromogenic coagulation assays and other ELISA based potency assays. The successful candidate will also review and/or prepare controlled documents related to release and stability testing of drug substance and drug product. Comfort with and understanding of industry standards for regulated pharmaceutical testing is required. The Senior Scientist will work in a team environment with members of the analytical and formulations group along with scientists from related discipline throughout the company.

Responsibilities:
• Responsible for assay development/qualification/troubleshooting and assay transfer to Contract Testing Labs
• Support characterization and comparability assessment of protein pharmaceuticals
• Provide technical support for analytical sections of regulatory filings
• Provide technical support for OOS/OOT and deviation investigations
• Plan and organize experiments to meet specific technical objectives
• Prepare and/or review written technical reports, SOPs and regulatory filings
• Adhere to company procedures and policies for laboratory documentation, safety and quality
• Use good scientific judgment in all activities
• Participate in group and individual meetings to establish priorities, organize activities and communicate results

Requirements


• Requires a PhD in a scientific discipline or equivalent industry experience and training; 10+ years of experience in a research or biotechnology/pharmaceutical drug development environment
• Proficient with ELISA, cell-based and binding assays, HPLC, SDS-PAGE, Western blot, CE-SDS ad cIEF
• Experience working with proteins and associated analytical methods
• Knowledge of relevant US/EU regulatory and quality requirements and standards
• Knowledge of Chromeleon and station software is a plus
• Knowledge of Good Laboratory Practices and/or Quality Control related cGMPs
• Ability to thrive in a small group setting with limited administrative support

Additional Information:

• Our company overview and history: http://www.portola.com/Company-Overview
• This position requires candidates to present a scientific seminar during the interview process
• Please include a cover letter that highlights your qualifications and matches our requirements