Research Scientist, Analytical and Formulation Development

South San Francisco, CA 94080

Posted: 07/28/2020 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 17722

Job Description


 

Research Scientist, Analytical and Formulation Development

The Opportunity

As Denali builds internal capabilities to support rapid process and formulation development for our diverse pipeline of large molecules, we are seeking a talented and motivated scientist with a passion for creative problem-solving to join our Analytical and Formulations Development group.  He/She will be responsible for developing analytical methods and performing in-depth characterization of product quality attributes in addition to supporting formulation development and optimization.  

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
  • BS./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

Marissa Kochan

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