Sr. Analytical Tech Transfer Associate I

Location
92121, San Diego
Posted
Oct 29, 2018
Discipline
Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

Let’s Make A Difference!

 

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing andaseptic drug product fill in vials and syringes.

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

Together, Let’s Make A Difference.

Ajinomoto Bio-Pharma Services is currently seeking a Sr. Analytical Tech Transfer Associate I with knowledge and experience in ICH, GDP, GMP and regulatory guidelines on method development, qualification, validation and technical writing. This role requires hands-on experience in analytical method transfer, method development, qualification and validation to support drug product and drug substance manufacturing including release and stability testing. 

The ideal candidate will have experience in electrophoretic methods such as iCEF and CE-SDS as well as experience in statistical analysis using JMP or Excel.

 

Responsibilities:

  • Follows method standard operating procedures (SOP’s) and conducts analytical method transfer. Develops, qualifies, and validates analytical methods with supervision.
  • Analyzes in-process, release and stability samples by battery of analytical methods and troubleshoots when necessary.
  • Writes SOPs, qualification and validation protocols and reports in collaboration with other team members.
  • Data review, interpretation, and presentation (team and project meetings).    
  • May act as project lead and work with both internal and external customers.

 

Requirements:

  • Bachelor’s degree in a Life Sciences discipline or equivalent required.
  • Minimum of six (6) years of experience in Analytical Chemistry mainly in HPLC and wet lab methods. Technical expertise in analytical method transfer, qualification, and validation; hands-on experience in HPLC and other chromatographic, spectrophotometric and wet lab chemistry methods.
  •  Experience in visible, sub visible, sub-micron particle analysis and characterization is advantageous.
  • Critical thinking and excellent verbal and written communication skills.
  • Ability to partner effectively in a matrix environment.

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

Successful candidate must pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.

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