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Sr. Research Associate I/II, Bioanalytical Sciences

BioMarin


Location:
SAN RAFAEL, California 94901
Date:
06/12/2018
2018-06-122018-07-12
Job Type:
Employee
Job Status:
Full Time
BioMarin
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Job Details

Summary:

The Senior Research Associate I/II (SRA) is a dynamic individual that is looking to advance their bioanalytical scientific acumen while applying a thorough understanding of laboratory regulations and compliance, bioanalytical clinical and non-clinical study support and contract vendor oversight.  This role within the organization requires the ability to pivot between a diverse range of responsibilities and to demonstrate technical and scientific leadership within the BioAnalytical Testing group.  The SRA is responsible for oversight and execution of analytical methods that measure pharmacokinetics, immunogenicity, biomarkers, vector and therapeutic genome.  Bioanalytical support encompasses laboratory work ranging from routine to complex in nature, data analysis, technical reports and presentations.  A SRA is an important member of a BioAnalytical team that provides key data to support regulatory submissions that can lead to approval of drug candidates.

 

 

Responsibilities:

  • A working knowledge of current techniques for bioanalytical methods such as ligand binding assays, cell-based assays , and PCR (including qPCR and ddPCR)
  • Ability to design and lead methodology and technology transfer within the department, as well as to external contract laboratories, ensuring GxP compliance
  • Ability to lead assay validation and testing laboratory work, data collection, data review and analysis, and report generation, compliant with FDA Guidance for Industry and EMA requirements
  • Is adept at assay troubleshooting and maintenance activities and applies innovative thinking to address new challenges
  • Has the ability to recognize deviations from accepted practice
  • Provides analytical and technical guidance/training for other research associates
  • Works with other members of the BioAnalytical Team to meet program timelines and deliverables, taking a leadership role when needed
  • Will author department documentation such as SOPs, protocols, reports, deviations, and investigations
  • Works independently with minimal supervision and able to manage concurrent projects 

 

Experience

  • Demonstrates good interpersonal skills showing initiative and resourcefulness
  • Demonstrates strong scientific and critical thinking skills
  • Excellent organization, written, and verbal communication skills
  • PCR validation experience a plus.
  • At least 4-6 years of bioanalytical experience
  • Requires experience with GxP regulations, requirements, and testing; GLP experience preferred
  • SRA I requires a Bachelor’s degree and at least 6 years of relevant experience in a bioanalytical laboratory, research laboratory, or biotechnology company; Master’s degree with at least 4 years of relevant experience
  • SRA II requires a Bachelor’s degree and at least 8 years of relevant experience in a bioanalytical laboratory, research laboratory, or biotechnology company; Master’s degree with at least 6 years of relevant experience

Education:

  • Bachelor’s or Master’s degree or equivalent experience with bioanalytical assays or other quantitative and semi-quantitative bioanalytical methods in a biological or biochemical field.

Equipment:

  • Familiarity with various software programs including, but not limited to, Word, Excel, Access, Powerpoint, Watson LIMS, Electronic Laboratory Notebooks, and JMP statistical software or equivalent
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