Research Scientist - Formulation and Lyophilization

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 formulationrelated challenges.

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 assistcustomers in advancing healthcare initiatives. Working across discovery research cell and gene therapy reproductive medicineand cytogenetics as well as the largescale production of biotherapeutics and vaccines the Company istrusted by researchers manufacturers and over 50 years FUJIFILM Irvine ScientificsMission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in itsproducts and custom solutions providing customers with the vital resources needed to enrich human lives through innovative accessible therapies. The Companysfacilities 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 centerin China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability ValuePlan 2030 for sustainable growth. FUJIFILM Irvine Scientific Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

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 scaleup of formulation and lyophilization processes for pilot and GMP manufacturing.
• Present formulation data to crossfunctional teams and contribute to regulatory documentation.
• Provide scientific guidance to junior team members and support troubleshooting of formulationrelated challenges.

Required Skills/Education

• B.S. with more than 8 years M.S. with 35 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 handson 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 SECHPLC 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 participation in project timeline setting with other departments).
• Intermediate business acumen learning/ understanding fundamental business concepts (i.e. general understanding of concepts and the ability to apply them to NPD).

Desired Skills

• Strong understanding of the functions of other departments and able to work interdepartmentally/ cross functionally.
• Strong creative/ innovating thinking skills intermediate level application of thoughts to process/ workflow improvements & product development.
• Actively participates in scientific discussion (e.g. meetings) demonstrating complex scientific/ critical thinking.
• Able to interact with upper management/ executive officers in a professional manner expressing ideas and opinions clearly and concisely.
• Ability to speak read and write English proficiently.
• Good oral and written communication skills

Benefits

• Medical Dental Vision
• Life Insurance
• 401k
• Paid Time Off

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