Research Associate 2, Bioanalysis, BioAnalytical Sciences

Location:  San Rafael, California Category: Research

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY:

Critical to the success of each new therapeutic, the Bioanalysis group characterizes, validates, and performs novel assays to measure pharmacokinetics, immunogenicity, and biomarkers. We are searching for a highly motivated Research Associate to characterize/validate, implement, perform, and maintain assays for gene therapy and oligonucleotide modalities. The ideal candidate has a flexible mindset and natural curiosity and motivation to understand and apply the underlying biology of our therapeutics as well as assay immunochemical theory to their daily work.  This position will be laboratory focused and offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early non-clinical programs through all stages of clinical development.  In addition, dynamic resourcing will provide opportunities for the RA to partner with our assay developers to build technical and analytical skills with new methods and new technology.  Opportunities may also include working with our partners in Molecular Medicine and Assay Strategy and Development on exploratory and investigative studies to better understand the underlying mechanisms of our therapeutics. The successful candidate will interact across BioAnalytical Sciences as well as with key collaborator and stakeholder groups such as the entire set of Translational Sciences functions, contract vendor laboratories, Clinical Laboratory Biospecimen Management, and GLP-Compliance to advance our most promising pipeline candidates. You will be able to learn and apply new platforms that further accelerate drug development, while maintaining a critical eye on assay quality and maintaining regulatory standards. 

Candidates with strong laboratory experience with molecular biology analyses, such as leading analytical projects and implementing new molecular biology analyses, may be considered at the SRA level

RESPONSIBILITIES:

  • Perform a variety of analytical methods to detect biomarkers, drug, and antibodies to therapeutics in biological matrices. Techniques include (but are not limited to) cell-based assays and molecular biology methods such as nucleic acid extraction, reverse transcription (RT), and polymerase chain reaction (PCR), ddPCR, and RNA sequencing.
  • Perform quantitative analysis within and across multiple experiments, including basic statistical and graphical analysis.
  • Present results, conclusions, and implications to BioAnalytical Sciences groups.
  • Prepare SOPs and other reports and documents to support nonclinical and clinical programs and associated regulatory submissions. This includes assay validation protocols, assay characterization and validation reports, reagent qualification reports, memoranda, and data reports for testing results.
  • Document all experimental procedures and data.
  • Share responsibility for lab maintenance duties.
  • Other duties as assigned which may include Bioanalytical Monitoring of assays outsourced to vendors for validation and testing.

 EXPERIENCE:

  • RA2:  4+ years experience in biomedical sciences, with demonstrated experience in a bioanalytical, clinical or nonclinical laboratory.  Two+ years of experience with molecular biology methods such as nucleic acid extraction, reverse transcription (RT), and polymerase chain reaction (PCR), ddPCR and RNA sequencing strongly preferred.
  • Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidance.
  • Excellent verbal and written communication skills: ability to cogently prepare and present data in group settings, prepare formal reports, give and receive useful feedback.
  • Ability to use computer effectively for data analysis and presentation.

 EDUCATION:

  • RA2:  Bachelor (BS / BA) degree in a biological or biochemical field, with 4+ years relevant experience, Masters (MS) degree in a biological or biochemical field, with 2+ years work experience with in a bioanalytical, clinical or nonclinical laboratory with 2+ years of molecular biology experience.

 

LEVEL DIFFERENTATION

  • RA 2: Bachelor and 4+ years industry experience or Masters and 2+ years industry experience
  • SRA 1:  Bachelor and 6+ years industry experience or Masters and 4+ years industry experience


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.