Senior Analytical Development Scientist, Cell Therapy

IT ENGAGEMENTS INC; California; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

IT Engagements Inc. is sourcing an experienced Scientist III for its Analytical Development team in San Diego, CA. The role focuses on developing and applying advanced analytical methods for cell therapy product release and characterization, with DoE-driven study design and cross-functional collaboration.

The candidate should have a strong track record in analytical development, process transfer, and regulatory documentation, capable of leading multiple projects in a fast-paced environment.

Qualifikationen

• Master's degree with 6-9+ years in analytical development, QC, tech transfer and method lifecycle management.
• PhD in a relevant scientific discipline with 2+ years of industry experience.

Aufgaben

• Develop or adapt analytical methods for cell therapy release and characterization by designing and executing DoE studies.
• Design and execute exploratory experiments to define CQAs and optimize analytical methods.
• Independently research, plan and execute experiments and analyze data to determine next steps.
• Perform risk and gap assessments for analytical methods to enhance compliance and robustness.
• Execute routine laboratory experiments with junior staff to generate high-quality data.
• Document study outcomes and present to stakeholders.
• Lead method development, transfer, and qualification for process development and release.
• Author SOPs, reports, and regulatory documents, ensuring high technical standards.

Kenntnisse

DoE design

Data analysis

Analytical development

Regulatory understanding

Communication

Ausbildung

Master's degree with 6-9+ years experience in analytical development

PhD in Immunology/Molecular Biology/Biochemistry or related

Tools

None

Jobbeschreibung

IT Engagements Inc. is sourcing an experienced Scientist III for its Analytical Development team in San Diego, CA. The role focuses on developing and applying advanced analytical methods for cell therapy product release and characterization, with DoE-driven study design and cross-functional collaboration.

The candidate should have a strong track record in analytical development, process transfer, and regulatory documentation, capable of leading multiple projects in a fast-paced environment.