Research Associate 1, Analytical Services

About the role

BioMarin’s Technical Operations group is responsible for creating and scaling production of drugs for clinical trials and commercial markets. This includes building and maintaining advanced manufacturing processes, ensuring quality through QA/QC, and procuring necessary goods and services.

Responsibilities

• 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
• 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
• Support efforts to provide technical support to regulatory agency inspections and audits
• 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)
• Produce high-quality data and documentation
• Support or lead laboratory investigations to identify the root cause and establish effective corrective and preventative actions

Requirements

• 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

Qualifications

• Bachelor’s degree 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

Skills

• Experienced in method development, qualification, and transfer
• Knowledge of biopharmaceutical development is a plus
• Experience working in a cross-functional environment

Pay

N/A

Schedule

Full-time