Research Associate 1, Analytical Services

biomarin; Novato (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

BioMarin is seeking a Research Associate in Analytical Services based in Novato, California. This vital role involves applying technical expertise in a laboratory setting to advance therapeutics for clinical evaluation and commercialization, ensuring compliance with GxP standards.

The candidate will conduct various analytical tests, maintain regulatory readiness, and support cross-functional teams. A Bachelor's degree in Chemistry or related field with 2–4 years of experience is required. Excellent communication and organizational skills are also essential.

Qualifications

• 2–4 years of experience in a Biologics or Pharmaceutical environment.
• Experience with method development, qualification, and transfer.
• Knowledge of GMP/GLP requirements.

Responsibilities

• Lead and perform analytical testing and method optimization.
• Ensure compliance with regulatory standards.
• Provide laboratory support to cross-functional teams.

Skills

Experience in analytical methods (HPLC/UPLC, etc.)

Ability to analyze and interpret data

Good written and oral communication skills

Strong organizational skills

Flexibility and execution skills

Education

Bachelor’s in Chemistry, Biochemistry, Analytical Chemistry or related field

Job 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 coordinate the worldwide movement of our drugs to patients.

Job Title

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

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.