Scientist - Protein Mass Spec
Orange County Metro Area, CA
The Scientist (Biologics Separation Sciences and Mass-Spectrometry) will be responsible for development and validation of HPLC-based and mass-spectrometry based methods for the separation, qualification, and characterization of proteins and peptides.
Functions as a resource in the application of separation sciences (e.g. HPLC, UPLC, CE, cIEF) and mass-spectrometry (e.g. intact mass analysis, peptide mapping, post-translational modifications) to biological systems (i.e. proteins, peptides, protein mixtures).
Establishes strategies for the development of analytical methods to separate impurities and monitor purity and stability of biopharmaceuticals and protein reagents as well as development of analytical methods for mass-spectrometry based characterization of biopharmaceuticals and protein reagents.
Must ensure the work is performed in a timely manner and consistent with regulatory expectations.
Provides scientific leadership as an expert in separation sciences and mass-spectrometry of biologics.
Contributes to the establishment of strategies for the development of analytical methods to monitor purity and stability of biopharmaceuticals and protein reagents.
Familiarity with biophysical characterization techniques is a plus.
Additionally, the scientist is responsible for maintaining instruments and other applicable laboratory equipment/devices.
Represents at in-house team meetings and in external scientific and regulatory meetings.
Additional requirements: Must work with, and/or supervise staff handling potent neurotoxins and in-process samples that may contain toxin-expressing organisms.
Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.
Education and experience:
Strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation with emphasis on separation sciences and mass-spectrometry based methods. Familiarity with biophysical characterization methods is a plus.
This experience is generally acquired through a combination of appropriate education (Ph.D) and 0-4 years of applied experience. Individuals with a MS degree and 6 or more years of applied experience may also qualify.
Essential Skills and Abilities:
Extensive experience with a wide variety of separation sciences techniques (e.g. HPLC, UPLC, CE, cIEF) as well as mass-spectrometry based techniques (e.g. intact mass, peptide mapping, post-translational modifications) as applied to biopharmaceuticals and protein reagents.
Skilled in the application of scientific design principles and analytical methodologies to the problems associated with biologicals and/or biopharmaceutical development.
Excellent instrument skills including the use of the associated software.
Excellent writing and communication skills.
Experience with performing characterization work for regulatory submissions and/or the development of methods for application within a QC environment is a plus.
Leadership skills sufficient to motivate and develop a small group to ensure maximal productivity and quality results.
A working knowledge of the requirements of working in a GLP or cGMP environment is helpful.