Associate, QC Stability & Reference Material Data

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 Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

Role

The QC Stability and Reference Material Data Associate is accountable for maintaining all aspects of the BioMarin Reference Material program, including but not limited to generating reference material qualification protocols, qualification reports for new reference standards, qualified range reports and periodic requalification reports. The individual prepares stability trend graphs and analyses for drug substance, drug product and reference materials to support regular product team updates, regulatory responses, and annual reports.

The scope of the position covers both clinical and commercial programs across multiple therapeutic platforms.  The individual is responsible for ensuring that functional objectives are aligned with company goals and multi-national regulations. The individual interfaces with QC Product Coordination, QC testing groups (QC Product, QC Analytical, and QC In-Process), Analytical Chemistry, Process Development, QA, and Regulatory Affairs, to ensure timely completion of reference material testing and result documentation.

This position requires practical knowledge of LIMS, Trackwise, and Quality System attributes (Quality Events, Deviations, CAPAs, and Change Requests). The individual possesses skills in data trending software (JMP, Discoverant), and Statistical Process Control (SPC) Charts. Strong interpersonal skills are required to interact with multiple cross-disciplinary departments, and effectively function as a member of teams.  Ability to train staff, at all levels, in use of software and data trending procedures is required. The individual performs most duties with a high degree of independence and minimal supervision. 

Key Responsibilities

• Prepares technical reports for reference material qualification protocols, qualification of new reference standards, establishing qualified ranges and periodic reference requalification.
• Ensures timely completion of reference material testing and result documentation.
• Initiates and completes Quality System processes in Trackwise.
• Maintains reference material trending graphs to monitor assay performance and suitability of qualified ranges.
• Performs data queries in LIMS to monitor testing status of commercial and clinical products.
• Prepares stability trend graphs for reference materials and drug substance / drug product stability studies, for reference requalification reports, and Product Quality Team updates.
• Supports graphic trend analysis for annual reports, regulatory submissions (APR, YBPR, BLA, IND), and response letters for all commercial/clinical products.
• Coordinates reference material vialing process with sample management team, including continuous process improvement (e.g. automation).
• Supports development of data trending tools for hands-on use by the Quality organization (e.g. QC Site Testing groups in Novato and Shanbally.) by testing enhanced systems, preparing work instructions and training personnel.
• Works with ambiguity and complexity to continuously modify options and solutions.
• Applies sound problem-solving skills to recommend options and implement effective solutions.
• Other duties as assigned.

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.