Process Scientist MSAT

Position Overview

We are hiring a Process Scientist, MSAT. The MSAT Process Scientist applies scientific, formulation, and process-development expertise to develop, characterize, scale, transfer, troubleshoot, and improve manufacturing processes for custom and catalog products. The role designs and executes studies and test batches, leads scientific aspects of technical investigations, and translates experimental findings into robust formulations, process controls, and manufacturing recommendations that support safe, compliant, scalable, and repeatable production.

Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Responsibilities:

• Technical Investigations and Manufacturing Support
  • Lead or support scientific investigations of deviations, process failures, adverse trends, complaints, audit findings, raw-material issues, and unexpected product performance.
  • Define technical problems and investigation strategies; apply solution chemistry, formulation knowledge, root-cause analysis, risk assessment, and data analysis to identify and verify potential causes.
  • Design confirmatory studies and recommend corrective actions, process controls, specifications, or monitoring plans.
  • Provide scientific support during manufacturing events, process start-ups, and implementation of corrective or preventive actions.
• Test Batches and Manufacturing Readiness
  • Lead planning and execution of test batches for new or modified custom and catalog powder and liquid products.
  • Support prototype production and laboratory studies that generate manufacturing-readiness and scale-up knowledge.
  • Establish objectives, acceptance criteria, sampling plans, technical deliverables, and assess formulation, material, equipment, process, and scale-up risks.
  • Provide technical oversight during execution, troubleshoot processing issues, and evaluate batch results.
  • Document conclusions, risks, recommendations, and manufacturing readiness; support prototype and laboratory studies needed for scale-up.
• Scientific Process Development and Characterization
  • Lead or support process development, characterization, optimization, and scale-up for new and existing products.
  • Design and execute studies evaluating formulation composition, raw-material attributes, material interactions, process parameters, equipment effects, and operating ranges.
  • Apply scientific and statistical methods to evaluate process variability, product quality, performance, yield, scalability, and robustness.
  • Translate results into manufacturing recommendations, process controls, operating ranges, specifications, and follow-up studies.
• Formulation Science and Manufacturability
  • Assess custom and catalog formulations for technical feasibility, manufacturability, and scale-related risk.
  • Evaluate ingredient compatibility, solubility, stability, sequence of addition, hydration, filtration, turbidity, particulates, and raw-material effects on process and product performance.
  • Recommend formulation or processing options that protect product quality and biological performance.
  • Prepare formulation instructions and technical assessments and collaborate with R&D/Product Development and Manufacturing to resolve manufacturability gaps.
• Technology Transfer and Cross-Functional Support
  • Support technology transfer by providing formulation, process, raw-material, and scientific knowledge and participating in readiness, risk, and technical-gap assessments.
  • Prepare or review scientific content for transfer packages, manufacturing instructions, protocols, reports, specifications, and investigation records.
  • Support transfer execution, troubleshooting, training, validation, change control, and implementation of new or modified formulations and processes.
  • Present technical findings and recommendations to cross-functional stakeholders and maintain current knowledge of relevant scientific, industry, and regulatory developments.
• Other science-related duties and responsibilities may be assigned as needed.

Required Skills/Education:

• B.S. Biology, Chemistry or related field, M.S. or advanced degree preferred.
• 5+ years of relevant scientific or process-development experience. Experience in formulation science, manufacturing process development, experimental design, scale-up, test-batch execution, technology transfer, or technical investigations is required. Experience with cell-culture media, buffers, liquid and powder manufacturing, and regulated manufacturing environments is preferred.
• Cell-culture media, buffers, solution chemistry, formulation principles, and raw-material functionality.
• Experimental design, scientific-method application, statistical analysis, and interpretation of complex data.
• Process development, characterization, scale-up, test batches, and manufacturing-readiness assessment.
• Root-cause analysis, risk assessment, FMEA, and structured problem-solving.
• cGMP, deviations, CAPA, change control, validation, and controlled technical documentation.
• Ability to translate scientific data into practical manufacturing recommendations, specifications, controls, and implementation plans.
• Technical writing, presentations, cross-functional collaboration, and project management.
• Microsoft 365 and applicable laboratory, statistical, quality, and manufacturing information systems.
• Experience with statistically designed experiments (DoE) a plus.
• Ability to speak, read and write English proficiently.
• Good oral and written communication skills

Salary and Benefits:

• For California, the base salary range for this position is $91,105 - $118,752. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

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EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).