Scientist Analytical Development

Scientist is an individual contributor responsible for analytical method development characterization testing data analysis and report for multiple cell types in support of cell therapy processes. The candidate will serve as subject matter expert for various analytical techniques. The candidate must be able to quickly adapt and learn new techniques and methodologies. The role requires strong technical expertise communication leadership and project management skills. The candidate must have strong laboratory skills bioassay cell biology and immunology experience. Role requires a selfmotivated detailed oriented flexible and creative expert able to prioritize multitask and work in a fastpaced & demanding environment.

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.

Reports to: Senior Manager Analytical Development

Location: Thousand Oaks CA

Travel: Up to 10

Primary Responsibilities:

• Develop execute and qualify analytical methods for cell therapy products: cell counting Tcell activation proliferation cytotoxicity flow cytometry and molecular assays such as ddPCR and qPCR.
• Analyze data review report and communicate results.
• Develop procedures for laboratory equipment use and maintenance.
• Develop assay templates that can serve as platforms for multiple cell types or methods as applicable.
• Ensures availability of materials and equipment required to implement analytical methods.
• Support instrument evaluation qualifications and change control assessments as needed.
• Author review and approve analytical methods laboratory procedures method development reports method qualification protocols/reports risk assessments and technical reports.
• Identify and qualify critical reagents required for analytical methods.
• Train Analytical Development and/or Quality Control staff members in analytical methods equipment operations data analysis and reporting
• Assess analytical method performance.
• Maintain current knowledge of ICH and USP guidelines regulations and policies.
• Work closely with Quality Control and Quality Assurance to transfer and/or qualify analytical methods for clients from early clinical phase through commercial.
• Work closely with Process Development to ensure analytical method readiness and testing for development samples.

Qualifications:

• Bachelor of Science (B.Sc. with 5 years of experience or an equivalent combination of education; or Master of Science (M.Sc. with 3 years of experience; or PhD in Science (Molecular Biology Cell Biology or Immunology preferred) with 03 years of experience.
• Advanced knowledge in analytical methods and respective instrumentation
• Advanced knowledge of product testing and laboratory skills
• Advanced knowledge of computer and laboratory systems
• Excellent technical writing communication skills project management skills
• Strong experience in cell culture method development and qualification of cellbased bioassays flow cytometry and molecular assays (ddPCR qPCR) performed in cell therapy.
• Experience in statistical analysis.
• Independent decisionmaking capability and ability to think conceptually and understand impact of decisions critical.
• Ability to work independently able to take ownership of a given assignment proactively consulting other project team members and other department representatives for information or guidance as necessary.
• Strong leadership collaboration and organizational skills
• Selfstarter team player and good interpersonal skills
• Knowledge of relevant regulations and ICH and USP requirements
• Experience in GMP and method validation is preferred.
• Experience working in a contract manufacturing or testing organization is preferred.
• Role model for FDBC core values of Trust Delighting our Customers Gemba and Genki.

Salary and Benefits:

• $104000 to $130000 depending on experience
• Medical Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

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