Lab Operations, Associate 2

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

The Operations Associate II, Laboratory Operations function is to support activities according to established procedures to support one or more RED laboratories. This role entails performing tasks with minimal supervision, focusing on acquiring knowledge of lab operations through hands-on experience to facilitate day-to-day functions and achieve departmental objectives (for Research: development of first-in-class and best-in-class therapeutics, BAS: generation of clinical and non-clinical data).  The Laboratory Associate provides operational support to all RED laboratories throughout the product lifecycle, from early non-clinical stages to all phases of clinical development. This role may also assist with equipment, instrument or software validation projects to meet program objectives and deliverables.  Individuals in this role understand and can apply GxP regulations to various processes and technologies as they are used and evaluated prior to use for regulated testing. The OA II participates in laboratory equipment implementation projects, in audits and inspections related to their job functions.  Some of the major activities include Computerized Maintenance Management System (CMMS) entry, writing and/or follow up with deviations/corrective and preventive actions (CAPA), and developing or revising procedures and/or work instructions. The OA II will interact with Facilities, Instrumentation, Compliance and other departments necessary to maintain regulatory compliance and good business practices.  RESPONSIBILITIES

• Laboratory Execution and Documentation
• Perform procurement (e.g., through Coupa) and receipt of lab consumables/chemicals outside of the vendor management inventory program.
• Assist in buffer preparation activities.
• Perform glassware/washing/autoclave services.
• Adhere to laboratory safety protocols, ethical guidelines, and regulatory requirements
• Perform safety inspections of lab operations owned workspaces and maintain an inspection ready laboratory
• Maintain GxP compliance through adherence to SOPs and training requirements.
• Train other lab associates on laboratory procedures as required
• Support lab clean-outs and 5S implementation.
• Enter work orders to resolve facility issues (e.g., water leaks).
• Assist with lab improvement projects. Support equipment maintenance
• Write and execute procedures (SOPs) and other technical documentation
• Review relevant literature and make suggestions for application or troubleshooting of assigned tasks

 

• Equipment / Instrument Management
• Coordinate, schedule, and escort vendor service technicians for Preventative Maintenance and/or Corrective Maintenance Services.
• Schedule and execute internal maintenance cleaning, preventative Maintenance, and performance verifications through adherence to SOPs and defined intervals.
• Submit equipment requests and complete maintenance Work Orders within CMMS platform.
• Red tag equipment that is out of service.
• Schedule removal and/or disposal of equipment and supplies.

• Functional / Cross-Functional Participation and Leadership
• Participate in laboratory safety and process improvement initiatives (across RED)
• Evaluate existing processes and technology and identify opportunities for optimization or improvement
• Develop subject matter expertise in process, platforms or technology and contribute to th