Research Associate , Analytical Services

About Technical Operations

Bio Marin’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 Bio Marin’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 coordinate the worldwide movement of our drugs to patients.

Research Associate, Analytical Services

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 Bio Marin’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 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 Bio Marin’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…