Sr. Associate Analytical Development

Location
San Diego, CA, United States
Posted
Aug 22, 2018
Ref
1-170
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

PaxVax is a fast growing privately held global specialty vaccines company focused on the travel and endemic disease markets with a mission to develop and commercialize innovative vaccines against infectious diseases in a socially responsible manner. The company headquarters are located in Redwood City, California, and R&D and GMP manufacturing sites are located in San Diego, California and Bern, Switzerland. PaxVax has two commercial vaccines: Vivotif ® oral typhoid vaccine and Vaxchora ® oral cholera vaccine. Our clinical stage portfolio also includes vaccine candidates for pandemic influenza (H5N1), anthrax, and HIV, and we are pursuing preclinical programs in dengue, malaria, herpes, zika, and chikungunya. PaxVax is committed to continued growth in its product portfolio, and in continuing collaboration with academic, government, and industrial partners. More information is available at www.PaxVax.com.

Summary of Position:

The Analytical Development Senior Associate will primarily focus on development and performing physicochemical assays such as of HPLC, DLS, and MicroBCA for analysis of materials and processes required for the formulation, release, and stability of API and finished drug product following GLP and GMP guidelines. In addition, this position may develop and/or perform Gel electrophoresis, Immuno-assays disintegration, and other method as needed.

Specific Responsibilities:

  • Participate in development, qualification and validation Physicochemical assays such as of RP, SEC, HILIC, AEX HPLC, DLS, MicroBCA, pH and Appearance


  • Routine analysis of in-process samples


  • Perform release and stability testing of BDS and finished products


  • Manages test samples, reagents and reference standards used in the laboratory


  • Perform routine maintenance, calibration and qualification of laboratory equipment and instrumentation


  • Write, revise, and maintain all assay SOPs and worksheets, instrument SOPs, and other documentation as needed


  • Assist in maintaining inventories of chemicals, reagents, and reference materials


  • Close attention to detail and the ability to multitask


  • Analysis and interpretation of test results, identify deviations and make appropriate recommendations


  • Other duties and special projects as needed may be assigned


Requirements:

  • Knowledge of and hands on experience with chromatographic methods and Spectroscopic methods


  • Possess a strong work ethic along with a solid organizational, time management, problem-solving, and interpersonal skills


  • Demonstrated experience analyzing critical data and proactively solving problems


  • Excellent written and verbal communication skills


  • BS in Biochemistry, Chemistry or similar discipline with 5+ years' experience, MS with 2+ years' experience,


Preferred Qualifications:

  • Good understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP


  • Experience working independently and thriving in a fast-paced environment


  • Basic computer skills, including MS Word, Excel and Waters Empower


  • Cross trained in QC disciplines


  • Experience working with adenovirus


  • Method development experience