Quality Assurance Associate Jobs in Santa Rosa, CA

Description
About Technical Operations
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.
Research Associate, Analytical Services
JOB DESCRIPTION
Research Associate is an onsite laboratory position. The selected candidate will work in the Analytical Services team, under the Analytical Sciences group to assist in the advancement of BioMarin's therapeutics for clinical evaluation and potential commercialization. The selected candidate will be responsible for applying technical expertise to the execution of laboratory activities related to GxP and non-GxP testing of early clinical programs and their transition to late stage, commercial and post-commercialization.
Under limited supervision, the candidate will ensure phase-appropriate performance, troubleshooting, optimization, qualification, validation, and transfer of methods for testing pharmaceutical drug substance and drug product. In addition, this role will support training for site QC / Global QC / Contract Test Labs / In-Country Testing Laboratories personnel in new techniques and methods. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.
RESPONSIBILITIES
Responsibilities include, but are not limited to the following:
Method Qualification, Validation, Transfer and Optimization
• Lead and/or perform analytical testing such as HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays.
• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports
• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin's in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners
• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay
• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams
• Support the maintenance of method and analytical equipment performance
• Trend, analyze and interpret analytical results.
• Conduct data review and sign-off in applicable document and data management systems
• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process
Regulatory Compliance, Audit and Site Support
• Lead/support the effort to maintain the laboratory in an inspection-ready state including support of equipment management (e.g., check reference materials for expiration, etc.)
• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives
Cross-Functional Support
• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations
• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing
Process Improvement and Training
• Act as technical resource (SME) to train other Analysts in areas of expertise
• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.
Required Skills:
• Experience in performing one or more combinations of analytical methods including HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays Experience or understanding of GMP/GLP requirements.
• Ability to analyze and interpret data.
• Good written and oral communication skills, with the ability to communicate complex information.
• Strong organizational skills with the ability to effectively multi-task and prioritize.
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.
Desired Skills:
• Experienced in method development, qualification, and transfer.
• Knowledge of biopharmaceutical development is a plus.
• Experience working in a cross-functional environment.
Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support.
Education
• Bachelor's/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.
• A Master's Degree in a related field is desirable, but not required.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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.