Research Scientist, Analytical and Formulation Development

South San Francisco, CA 94080

Posted: 02/25/2020 Employment Type: Contract Industry: Clinical & Scientific Job Number: 17199

Job Description


Research Scientist, Analytical and Formulation Development

 

The ideal candidate has extensive hands-on experience in a wide array of analytical protein characterization and biophysical methods as well as a passion for working in the laboratory and applying their strong analytical thinking skills to further the understanding of complex molecules.

This is a laboratory-based position that offers opportunities to expand technical skills through mentorship from highly experienced laboratory scientists as well as opportunities to contribute to technical decision-making and learn outside of the laboratory through cross-functional development team meetings and coaching.  In addition, you will have development opportunities to take on additional responsibilities such as serving as a representative for analytical and formulation development.

Key Responsibilities
  • Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods to be used for product release, stability, and characterization testing.
  • Design and execute formulation development and stability studies to identify optimized formulations with a focus on understanding key degradation pathways.
  • Perform in-depth analytical characterization of complex biologics to build a strong understanding of critical quality attributes (CQA).
  • Generating, analyzing, and critically evaluating analytical data to support method development, product characterization, and formulation development.
  • Provide rapid and timely analytical support for cell-line, bioprocess, and formulation development activities.
  • Be actively engaged in cross-functional technical decision making.
  • Serve as analytical expert for transferring analytical methods to contract development and manufacturing organizations (CDMO) including performing reviews of GMP method qualification documents.
  • May serve as a technical representative for analytical and formulation development on cross-functional teams and at joint team meetings with CDMO.
  • Contribute to establishing internal state-of-the-art analytical capabilities to support accelerated CMC development.
  • Author technical documents including analytical test procedures, stability protocols, development reports, and sections of health authority filings.
  • Maintain timely and accurate lab records consistent with good documentation practices.

Requirements
  • B.S./M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, Bioengineering, or related scientific discipline with a minimum of 2 – 5 years analytical and/or formulation development experience for protein therapeutics in the biotech/biopharma industry.
  • In-depth knowledge and extensive hands-on experience in using a wide array of analytical protein characterization and biophysical methods (e.g. analytical UPLC-based methods, cIEF, capillary electrophoresis, spectrophotometry, light scattering, etc.) LC/MS, peptide mapping, spectrophotometry, SPR, light scattering, etc.)
  • Highly skilled at performing analytical characterization activities in the laboratory.
  • Prior experience applying mass spectrometry characterization methods (LC/MS, intact mass, peptide mapping, tandem mass spectrometry, quantitative analysis, hydrogen-deuterium exchange, etc.)  to protein therapeutics and/or bioanalytical assays (ELISA, SPR) considered a plus.
  • Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as CDMOs.
  • Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
  • Excellent laboratory, critical thinking, scientific problem-solving, and organizational skills.
  • Excellent oral and written communication skills.
  • Motivated, detail-oriented, naturally curious individual with a creative approach to scientific problem solving and a burning desire to help patients with neurodegenerative diseases.

 

Meet Your Recruiter

Ron Tess

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