Research Scientist - Formulation and Lyophilization

Position Overview

We are hiring a Research Scientist – Formulation and Lyophilization. The Research Scientist – Formulation and Lyophilization will be responsible for leading formulation development studies to improve solubility, stability, and bioactivity of recombinant cytokines and growth factors, design and execute lyophilization cycles with a focus on reducing moisture content, improving cake appearance, and maintaining activity. They will evaluate excipients and delivery system compatibility for liquid and lyophilized formats (vials, bags, etc.), and provide scientific guidance to junior team members and support troubleshooting of formulation-related challenges.

Company Overview

FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation. 

Job Description

Responsibilities 

• Lead formulation development studies to improve solubility, stability, and bioactivity of recombinant cytokines and growth factors.
• Work closely with downstream scientists
• Design and execute lyophilization cycles with a focus on reducing moisture content, improving cake appearance, and maintaining activity.
• Evaluate excipients and delivery system compatibility for liquid and lyophilized formats (vials, bags etc.).
• Author technical reports, batch records, and development protocols.
• Collaborate with analytical teams for stability studies and characterization.
• Support scale-up of formulation and lyophilization processes for pilot and GMP manufacturing.
• Present formulation data to cross-functional teams and contribute to regulatory documentation.
• Provide scientific guidance to junior team members and support troubleshooting of formulation-related challenges.

 

Required Skills/Education 

• B.S. with more than 8 years, M.S. with 3-5 years, or Ph.D. with less than 2 years of relevant working experience in Biochemistry, Pharmaceutical Sciences, or a related field.
• Relevant work experience with proteins and purification techniques are required.
• Able to troubleshoot equipment and experimental problems independently.
• Perform advanced data analysis, use of statistical software and generate summary data reports & presentations (creation understandable graphical representations of data).
• Able to prepare formal reports and presentations independently with review/ very minor edits from supervisor.
• Able to interpret scientific literature, apply knowledge to projects (e.g. experimental design information, concentration ranges, etc.), use information to develop new and novel ideas/concepts/product development.
• Able to design scientifically sound experimental designs with minimal guidance.
• Strong experience in protein formulation development, particularly for biologics or therapeutic proteins.
• Proven hands-on experience with lyophilization cycle development and thermal characterization techniques.
• Familiarity with delivery system development for liquid and lyophilized formats
• Knowledge of protein stability, aggregation, and degradation pathways.
• Experience with analytical tools such as SEC-HPLC, DLS, UV, and CD preferred.
• Excellent data interpretation and scientific communication skills.
• General knowledge and application of project management skills.
• General understanding of the NPD/ phase gating process and function, able to apply this knowledge and support projects independently (i.e. completing check list items, p