Sr. Research Associate II, Assay Strategy and Development

Location:  San Rafael, California Category: Research

Description

DESCRIPTION

The Assay Strategy and Development (AS&D) group within the BioAnalytical Sciences (BAS) department at BioMarin develops and characterizes novel assays to measure pharmacokinetics, immunogenicity and biomarkers of new therapeutics.  We are searching for an experienced bench scientist to oversee the transfer and validation of bioanalytical assays at Contract Research Organizations (CROs), as well as use of these assays to test samples from non-clinical and clinical studies. The individual will also be called upon to develop and characterize innovative assays to assess the safety and efficacy of new therapeutics in development.  This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early proof of concept non-clinical work through all stages of clinical development, including post-approval.  The successful candidate will interact with Research, Translational, and Clinical Scientists to advance our most promising pipeline therapeutics focused on rare diseases. 

We are looking for a self-motivated and driven bench scientist with 4-8 years of assay development experience, who has a track record for building pharmacokinetic, biomarker and immunoassays that have been critically reviewed by regulatory agencies. 

This Senior Research Associate position will report to a Senior Scientist in AS&D and will have the opportunity to influence the evolution of the BioAnalytical Sciences department in a growing biotech company and positively impact the lives of patients with rare diseases.

RESPONSIBILITIES

  • Bioanalytical monitoring of outsourced assays for assay transfer, assay validation, sample testing, and assay performance metrics; experience with managing vendors preferred.
  • Develop a variety of analytical methods to detect biomarkers, drug, and antibodies to protein therapeutics in biological matrices. Techniques may include (but are not limited to) ELISA, ECLA, nucleic acid extraction, droplet digital polymerase chain reaction (ddPCR), ultrasensitive protein assays, cell-based and ex vivo culture assays.
  • Develop new techniques, or bring in new technology from the outside, to enhance the analytical capabilities of the group.
  • Present results, conclusions, and implications to Assay Strategy & Development, BioAnalytical Sciences, and Translational Sciences groups and cross-functionally.
  • Meticulously adhere to electronic data recording standards.
  • Share responsibility for lab management duties.
  • Participate and present data as a member of BioAnalytical teams and share responsibility for project milestones.
  • Present data and participate in discussion in Translational Sciences/Research and Early Development and other cross-functional team meetings as necessary.
  • Participate in external scientific meetings and contribute to original peer-reviewed publications.
  • Other duties as assigned.

 

EXPERIENCE

  • 6+ years experience in biomedical sciences.  Advanced degree or bachelor’s degree with demonstrated experience as an independent scientist in a biotech setting.
  • Broad technical proficiency and ability to solve complex scientific and technical issues independently.
  • Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidances.
  • Excellent verbal and written communication skills: ability to cogently prepare and present data in group settings, prepare formal reports, communicate across functions.
  • Strong teamwork skills – ability to solicit, receive, and give useful feedback.
  • Ability to use computer effectively for data analysis and presentation.
  • Strong working knowledge of molecular and cell biology and biochemistry, with deeper expertise in at least one area.
  • Demonstrated experience initiating new methods or technologies in an experimental laboratory setting.

 

EDUCATION

  • Bachelor’s or Masters degree with 4 to 8 years experience performing molecular biology, immunoassays, cell-based assays, or other analytical methods in a biological or biochemical field. Working knowledge of cell and molecular biology and biochemistry.