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 self-motivated, detailed oriented, flexible, and creative expert, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
Reports to: Associate Director, Analytical Development
Location: Thousand Oaks, CA
Travel: Up to 10%
Primary Responsibilities:
- Develop, execute, and qualify analytical methods for cell therapy products; including but not limited to: cell counting, T-cell activation, proliferation, cytotoxicity, or flow cytometry.
- 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 base of ICH 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 0-3 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, analytical method development and qualification (bioassays, flow cytometry and other techniques performed for cell therapy)
- Experience in statistical analysis
- Independent decision-making 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
- Team player and good interpersonal skills
- Knowledge of relevant regulations and ICH 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:
- $104,000 to $130,000 per year, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
Join us! FDB is advancing tomorrow’s 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.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
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 via-email, 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.
