B.S. in Biology, Chemistry, or related field; M.S. or advanced degree preferred.
5+ years of experience in scientific or process development, particularly in formulation science and manufacturing.
Strong knowledge of cell-culture media, buffers, and solution chemistry.
Proficient in experimental design, statistical analysis, and data interpretation.
Experience with cGMP, CAPA, and technical documentation in regulated environments.
Excellent technical writing and communication skills.
Responsibilities
Lead scientific investigations of manufacturing deviations and process failures.
Design and execute confirmatory studies to recommend corrective actions.
Plan and execute test batches for new or modified products.
Provide technical oversight during manufacturing events and troubleshoot issues.
Assess formulations for manufacturability and scale-related risks.
Support technology transfer and prepare scientific content for transfer packages.
Present technical findings to cross-functional stakeholders.
Benefits
Medical, Dental, Vision coverage.
Life Insurance.
401k retirement plan.
Paid Time Off.
Full Job Description
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.
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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About Fujifilm Manufacturing USA, Inc
Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
