Sr. Research Associate I, Critical Reagents - BioAnalytical Sciences
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.
BioAnalytical Sciences develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-human and human subjects to support projects through multiple stages of development. The Senior Research Associate (SRA) independently plans, performs and manages activities required for Critical Reagent preparation, characterization, and release testing while exercising significant technical discretion. Specifically, this position will be a critical service to the assay
development and testing groups by building and continuously supplying customized protein reagents for internal and outsourced assays . The individual will manage the development and quality of Critical Reagents by standardizing methods and techniques for critical reagent generation to ensure reproducible testing results, implementing a reagent characterization regimen and lifecycle management system, and ensuring accurate and complete reagent documentation to facilitate efficient data retrieval and sharing to expedite decisions. The SRA may present results to project teams through presentations, internal reports, or outside publications.
Produce consistently prepared and well characterized reagents to reduce the risk of assay failure and ensure methods meet regulatory requirements. Responsible for the development and quality of Critical Reagents including managing external antibody immunization campaigns, building isotype-specific antibody reagents, purifying proteins, conducting protein conjugations (e.g. biotinylation, ruthenylation using standard chemistry), assessing their purity and affinity, and generating Certificates of Analysis. Monitors and or trend lot-to-lot variability, and may assist with reagent troubleshooting Develop new techniques , or bring in new technology from the outside, to enhance the analytical capabilities of the group. Prepare SOPs, reports and documents such as characterization protocols, development reports, and testing data reports. Independently carry out the aforementioned tasks and plan, implement, and complete significant projects with minimal supervision. Share responsibility for lab management duties. May supervise one or more Research Associates.
Scope: Responsible for efficient and effective laboratory operations, the Senior Research Associate has a significant impact on the company's ability to reach project goals in a timely manner with respect to delivery of data to support preclinical and clinical studies critical to advancing programs through the development process. Experience & Education:
Bachelor's degree in biology, biochemistry or related field with at least 6 years of experience - OR a Master's degree with at least 4 years experience. Required: At least 4 years of experience in a laboratory, research laboratory, or biotechnology company working with antibody and protein biochemistry. Preferred: Experience with GLP or GMP documentation. Preferred: Excellent writing and verbal communications skills.
Work Environment/Physical Demands: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Equipment:
Multi-well absorbance, electrochemiluminescence and fluorescence plate reader and associated software. SDS-PAGE, Western Blot, Surface Plasmon Resonance Pipettors, plate washers and related assay equipment. Chromatography systems such as AKTA FPLC and Multiple Angle Light Scattering (MALS). Windows network environment, MS Office, etc.