Investigator BPT-A (Analytical Scientist)

Basic qualifications:

BS/BA in Life Sciences, Chemistry, Engineering or equivalent technical discipline

A minimum of 8 years experience in the Biopharmaceutical/ pharmaceutical industry

Expertise in analytical methods for process residuals (HCP, DNA, Protein A) and/or separation methods (LC, CGE, cIEF)

Experience with method transfers, qualification/validation

Familiarity with electronic data storage systems

Experience writing analytical documents and technical reports

Exemplary communication and problem solving skills

A sound background in analytical methodology and instrumentation

The ability to plan, execute and analyze experiments

Adherence to timelines

An enthusiastic attitude and a desire to work in a team environment which includes cross-functional interactions

Preferred qualifications:

MS degree

Experience with method optimization

Ability to take leadership on analytical projects involving multiple scientists

Working in a GMP environment

Experience with methods in addition to techniques listed above (SDS-PAGE, Biacore, or other)

Execution of analytical testing for process characterization, process validation, clinical release / stability, product characterization

Knowledge of FDA and/or European agency regulations on analytical methods

Details:

The BioPharmaceutical Technology department (BPT) has an opening for an Investigator in the analytical group. As part of the BPT-A team, you will:

  • transfer or develop methods into the site
  • optimize methods for GMP testing including qualification
  • perform testing for process characterization and validation, clinical release/stability and for product characterization
  • work with BPT upstream and downstream scientists on analytical setup and data interpretation
  • support manufacturing investigations
  • be the analytical SME in your area of expertise
  • mentor and train junior analysts
  • write analytical protocols and reports
  • represent BPT-A in meetings with Rockville and off-site clients

Description of department: The analytical group of the Biopharmaceutical Technology department (BPT-A) is responsible for analytical Tech Transfer and method qualifications for protein biopharmaceuticals. The group further provides analytical support for BPT's upstream and downstream lab groups during process development, characterization and validation. Also, BPT-A performs testing for clinical stage projects in Manufacturing at Rockville.

Contact information:

You may apply for this position online by selecting the Apply now button.

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