Principal Scientist

Chesterfield, Missouri
August 03 2021
Position Type
Full Time
Organization Type

The qualified candidate will join the Analytical R&D (ARD) organization to enable development of biotherapeutics in Chesterfield, MO. Within Analytical R&D, the candidate will join the Project Progression & Biochemistry Group focused on monoclonal antibodies, oligonucleotides, vaccines, and other biological modalities. This group develops analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline; this includes method development, process support, formulation and stability support, product characterization, method qualification, method validation and method transfer. The candidate will be involved in the development and implementation of a mass spectrometry-based Multi-Attribute Method (MAM). Our MAM team uses this methodology and strategy to progress biotherapeutic products in the pipeline, provide process and formulation support, and conduct product characterization. The candidate must have strong skills in protein-based HPLC separations and mass spectrometry characterization. The candidate must be able to interact effectively with multi-disciplinary project teams. In addition, the candidate is expected to provide data interpretation for their teams and customers, and revise/review/author test methods, technical reports, and regulatory filings. The above skills will be applied to a large platform of projects in all stages of development.

  • Technical Leader: provide technical leadership in the characterization of biotherapeutics.
  • Project Leadership: potentially serve as an ARD Project Lead and lead Analytical sub teams across ARD.
  • Coach and mentor junior colleagues.
  • Responsible for building key analytical strategies and the development, validation, and transfer of assays for release and characterization of biotherapeutics.
  • Writing and reviewing technical reports, SOPs, validation reports, and regulatory documents (e.g., INDs, BLAs and queries).

  • Ph.D. (>4 yrs), MS (>9 yrs) or BS (>12 yrs) in analytical chemistry, biochemistry, or related field.
  • Experience with interdisciplinary biotherapeutic drug development teams and industrial experience developing chromatographic and electrophoretic assays to assess the quality and characteristics of biotherapeutic drug candidates.
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
  • Demonstrated technical writing skills.
  • Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.

  • Post-doctoral experience in developing /troubleshooting analytical methods for biotherapeutics.
  • The ideal candidate will have experience developing and using the following techniques: all modes of HPLC and MS for analysis and/or characterization of biologicals including; proteins, antibodies, peptides, and conjugates.
  • Understanding of emerging high-throughput technology platforms and applications to automate sample preparation and data analysis.
  • Experience setting and implementing analytical comparability strategies for glycoprotein therapeutics and/or vaccines.
  • Direct experience authoring and reviewing regulatory documents and working with FDA or European regulatory authorities.
  • Experience in sample preparation automation and data analysis.
  • Experience with method development and qualification.

Other Job Details
  • Last Date to Apply for Job: August 9, 2021
  • Eligible for Employee Referral Bonus: YES
  • Eligible for Relocation Package


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