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ragupathyrenganathan
Pharma Jobs! Quality Control Sr. Research Associate PaxVax, Inc.
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Location:

San Diego, CA

Posted Date:

6/24/2015

Position Type:

Full time

Job Code:

Salary:
Required Education:

Bachelors Degree

Areas of Expertise Desired:

Biology, Chemistry, QC,

Job Description

PaxVax, Inc. is an innovative pre-IPO specialty vaccine company with a mission to protect people from infectious diseases.  The Company will pursue a double bottom line strategy by pursuing financial returns from its specialty business strategies in travel and biodefense vaccines as well as social returns by providing access to its vaccines globally, particularly to the poor and otherwise disenfranchised. The PaxVax portfolio includes a licensed vaccine for typhoid (Vivotif®), vaccines in clinical development for cholera, anthrax, HIV, and H5N1 (pandemic bird flu) and in research for malaria, dengue, rabies and HSV.  The Company has raised more than $130 million (USD) from investors and other funders, including Ignition Ventures, Ignition Growth, the Wellcome Trust and the National Institutes of Health. The Company is headquartered in the San Francisco Bay Area with over 170 world class employees in Bern, San Diego, Redwood City and Miami.

The Quality Control Senior Research Associate will work specifically with High-performance liquid chromatography. This position will primarily focus on conducting HPLC analysis of materials and processes required for the formulation, release, and stability of API and finished drug product within standard operating procedures following GLP and GMP guidelines as well as the development, qualification and validation of HPLC methods.  In addition, this position may perform routine QC assays such as Karl Fischer, Disintegration, and gel electrophoresis.

Responsibilities
•   Perform quality control tests on raw materials, in-process samples, BDS and finished products
•   Responsible for the development, qualification and validation of HPLC assays
•   Responsible for the qualification and validation of HPLC instruments
•   Participate in HPLC instrument maintenance and troubleshooting
•   Manages test samples, reagents and reference standards used in the laboratory
•   Analysis and interpretation of test results, identify deviations and make appropriate recommendations
•   Write, revise, and maintain all QC assay SOPs and worksheets, instrument SOPs, and other documentation as needed
•   Evaluate trend data and author trend reports to proactively identify issues
•   Experience with cGMPs in accordance to FDA specifications
•   Close attention to detail and the ability to multitask
•   Other duties and special projects as needed may be assigned

Requirements

•   Knowledge of and hands on experience with HPLC
•   Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills
•   Demonstrated experience working independently and thriving in a fast-paced start-up environment
•   Demonstrated experience analyzing critical data and proactively solving problems
•   Bachelor’s Degree in Biology, Chemistry or similar discipline and 5 years of experience

PREFERRED QUALIFICATIONS
•   Cell culture experience is a plus
•   Cross trained in other QC analyst disciplines
•   Experience working with adenovirus
•   Method development experience

To apply, copy the link below
http://www.biospace.com/jobs/job-listing/quality-control-sr-research-associate-346271


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