Research Associate , Analytical Services

Position Overview

Research Associate is an onsite laboratory position in the Analytical Services team, under the Analytical Sciences group. The candidate will assist in advancing Bio Marin’s therapeutics for clinical evaluation and potential commercialization. Responsibilities include executing laboratory activities related to GxP and non‑GxP testing of early clinical programs and their transition to late stage, commercial and post‑commercialization. The role involves ensuring phase‑appropriate performance, troubleshooting, optimization, qualification, validation, and transfer of methods for pharmaceutical drug substance and drug product testing.

The candidate will support training for site QC, Global QC, Contract Test Labs, and In‑Country Testing Laboratories personnel in new techniques and methods. Excellent analytical, organizational and communication skills are required, self‑starter willing to work efficiently and collaboratively in a dynamic environment.

• 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 root cause and establish effective corrective and preventive actions with minimal delay.
• Provide technical expertise for analytical test methods (optimize, validate, 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 for 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., checking reference materials for expiration).
• Support efforts to provide technical support to regulatory agency inspections and audits (e.g., Pre‑Licensing Inspection (PLI) and periodic cGMP inspections).
• General understanding and application of USP, EP, JP and ICH regulatory guidelines and directives.
• 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.

• Experience performing analytical methods including HPLC/UPLC, electrophoresis, UV spectrophotometry, plate‑based assays, ELISAs, cell‑based bioassays, nucleic acid analysis and compendial physicochemical assays.
• Understanding of GMP/GLP requirements.
• Ability to analyze and interpret data.
• Excellent 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.

• Experience in method development, qualification and transfer.
• Knowledge of biopharmaceutical development.
• Experience working in a cross‑functional environment.

• 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.
• Master’s degree in a related field is desirable but not required.

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.