job summary: LTS Scientist III Job Summary
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.
location: Irvine, California
job type: Contract
salary: $38.00 - 44.71 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- 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 the client 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.
qualifications: Education & Qualifications
- Strong analytical and instrument skills and a thorough understanding and working knowledge of biophysical and analytical method development and validation with emphasis on biophysical methods.
- 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.
- Excellent writing and communication skills.
- Extensive experience with a wide variety of biophysical methods for protein characterization (light scattering, CD, AUC, DSC, ITC, fluorescence, subvisible particle analysis, etc) as well as related separation sciences techniques such as HPLC and capillary electrophoresis.
- 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.
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: HPLC, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.