Investigator BPT-A (Analytical Scientist)
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
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
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.
You may apply for this position online by selecting the Apply now button.
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