Research Associate 1, Process Analytics and Services (Analytical Sciences)

Posted Yesterday
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Novato, CA, USA
In-Office
Junior
Biotech • Pharmaceutical • Manufacturing
The Role
Performs routine and non-routine analytical testing for drug substance and drug product process development, lifecycle programs, manufacturing, release, stability, and investigations. Executes chromatographic, electrophoretic, spectrophotometric, plate-based, and cell-based assays; analyzes data; documents work under GMP/GLP requirements; supports method qualification, validation, transfer, troubleshooting, laboratory readiness, regulatory inspections, and cross-functional technical activities.
Summary Generated by Built In

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.
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.

SUMMARY
The Analytical Sciences department is seeking a Research Associate 1 to join the Process Analytics & Services (PAS) function. This is a hands-on laboratory role supporting analytical testing and characterization of therapeutic candidates across process development, early clinical, late-stage, and commercial programs.

The selected candidate will execute a variety of GxP and non-GxP analytical methods to support drug substance and drug product process development, method lifecycle activities, and cross-functional technical investigations. This role requires strong laboratory execution, data analysis, and collaboration skills in a fast-paced, multi-disciplinary environment.

KEY RESPONSIBILITIES

Analytical Testing & Data Execution

  • Perform routine and non-routine analytical testing to support process development (Drug Substance and Drug Product) and lifecycle programs
  • Execute assays including:
    • Chromatographic methods (e.g., HPLC/UPLC)
    • Capillary electrophoresis (CE) and gel-based electrophoresis (e.g., SDS-PAGE)
    • Spectrophotometric methods (e.g., UV/Vis, FTIR)
    • Plate-based assays (e.g., ELISA) and cell-based bioassays
    • Basic nucleic acid and compendial physicochemical testing
  • Accurately document test results in accordance with GMP/GLP and internal procedures
  • Analyze and interpret analytical data and communicate results clearly

Method Lifecycle & Laboratory Support

  • Support method qualification, optimization, validation, and transfer activities under supervision
  • Assist with drafting and updating technical documents (e.g., analytical procedures, protocols, reports)
  • Support troubleshooting of analytical methods and laboratory workflows
  • Maintain laboratory equipment and ensure readiness of reagents, standards, and materials

Process Development & Cross-Functional Support

  • Provide analytical testing support for process development, manufacturing, and investigation activities
  • Collaborate with cross-functional teams including:
    • Drug Substance Technologies (DST)
    • Formulation and Drug Product Technologies (FPT)
    • Manufacturing Sciences & Technology (MSAT)
    • Manufacturing, Quality Control, and Quality teams
  • Support in-process, release, and stability-related analytical testing

Compliance & Inspection Readiness

  • Ensure all work is performed in accordance with GxP requirements and BioMarin procedures
  • Maintain laboratory documentation and data in an inspection-ready state
  • Support regulatory inspections, audits, and site readiness activities

Data Management & Communication

  • Document experimental plans, results, and conclusions clearly and accurately
  • Maintain organized electronic records to ensure traceability and data integrity
  • Present data and progress updates in team meetings

Continuous Improvement & Team Support

  • Contribute to improvement of laboratory processes, workflows, and documentation practices
  • Support training and knowledge sharing within the team as appropriate

REQUIRED SKILLS

  • Hands-on experience with one or more analytical techniques (e.g., HPLC/UPLC, CE, ELISA, spectrophotometry)
  • Basic understanding of GMP/GLP principles and data integrity expectations
  • Ability to analyze and interpret data
  • Strong written and oral communication skills
  • Strong organizational skills with the ability to manage multiple tasks
  • Ability to work independently and collaboratively in a team environment

PREFERRED SKILLS

  • Hands-on experience with chromatographic (LC/HPLC/UPLC) and capillary electrophoresis (CE) methods
  • Exposure to biopharmaceutical development or protein characterization
  • Experience with bioassays or cell-based assays
  • Familiarity with analytical method lifecycle activities (e.g., qualification, troubleshooting, validation, or transfer)
  • Experience working in a cross-functional or fast-paced environment

EDUCATION & EXPERIENCE

  • Bachelor’s degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field
  • 1–2 years of relevant experience in a pharmaceutical or biotechnology environment
  • Master’s degree is a plus but not required

ADDITIONAL INFORMATION

  • This is a fully onsite laboratory role
  • Routine work includes handling chemicals and biological materials with appropriate safety practices
  • May require occasional flexibility to support operational needs
EQUIPMENT
Operation of standard laboratory equipment for biochemistry and for cellular assays

REPORTING STRUCTURE

  • Reports to: Sr. Manager, Process Analytics & Services
  • No supervisory responsibilities
 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
 

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. 

Skills Required

  • Bachelor's degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or a related field
  • 1-2 years of relevant experience in a pharmaceutical or biotechnology environment
  • Hands-on experience with one or more analytical techniques, such as HPLC/UPLC, capillary electrophoresis, ELISA, or spectrophotometry
  • Basic understanding of GMP/GLP principles and data integrity expectations
  • Ability to analyze and interpret data
  • Strong written and oral communication skills
  • Strong organizational skills and ability to manage multiple tasks
  • Ability to work independently and collaboratively in a team environment
  • Hands-on experience with chromatographic and capillary electrophoresis methods
  • Exposure to biopharmaceutical development or protein characterization
  • Experience with bioassays or cell-based assays
  • Familiarity with analytical method qualification, troubleshooting, validation, or transfer
  • Experience working in a cross-functional or fast-paced environment
  • Master's degree

BioMarin Pharmaceutical Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BioMarin Pharmaceutical Inc. and has not been reviewed or approved by BioMarin Pharmaceutical Inc..

  • Healthcare Strength Benefits are often characterized as comprehensive, spanning medical, dental, vision, life and disability coverage, along with FSAs/HSAs and an EAP. Feedback suggests these health offerings are consistently regarded as strong and at times "industry best".
  • Leave & Time Off Breadth Leave and time off are described as generous, with structured vacation progression, dedicated sick time, and a company-observed winter break among many holidays. Feedback suggests this breadth of paid time away is a standout element of the total rewards.
  • Retirement Support Retirement support is underpinned by a 401(k) savings plan with a company match. Feedback suggests these retirement programs contribute meaningfully to overall compensation value.

BioMarin Pharmaceutical Inc. Insights

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The Company
HQ: San Rafael, CA
3,270 Employees
Year Founded: 1997

What We Do

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact. Recruitment Fraud Alert Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral. In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity. If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit. We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.

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