Scientist I

4 weeks ago

FL United States Iovance Biotherapeutics Inc Full time
Job Summary

We are seeking a highly skilled Scientist I - Analytical Development to join our team at Iovance Biotherapeutics Inc. As a key member of our analytical development team, you will be responsible for leading and supporting assay qualification and GXP early-stage assay development projects.

Key Responsibilities
  • Develop and support analytical methods under GMP and ICH guidelines.
  • Collaborate with cross-functional teams to design and execute cell-mediated immunoassays (CMI) regulated studies.
  • Provide scientific input for assay format selection based on risk assessment and fit-for-purpose.
  • Develop, qualify, and validate analytical methods, including troubleshooting and sample analysis.
  • Assess and implement new technologies for cellular identification and characterization assays.
  • Serve as an internal subject matter expert on developed assays, providing technical support to internal and external laboratories.
  • Ensure assays are developed and executed per applicable Guidance and Regulations.
  • Contribute to regulatory filings pertaining to assay details.
  • Analyze and interpret experimental data independently.
  • Present and communicate results effectively to stakeholders and within a multi-disciplinary team environment.
Requirements
  • PhD with 2+ years of industry experience or master's degree with 5+ years of industry experience in Immunology, Cellular, or Molecular Biology field.
  • GMP or Quality experience with proficiency in regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Clinical (Research) Practices (GCP), ICH standards for analytical test methods.
  • Prior experience developing and supporting T cell and genome editing cell therapy product development.
  • Knowledge of medical terminology and intellectual capacity to use judgment and critical thinking skills to ensure data accuracy, logic, and consistency with internal and regulatory reporting requirements.
  • Able to work in a fast-paced, collaborative environment and manage multiple concurrent projects with high independence.
  • Strong interpersonal, written, and oral communication skills.
Work Environment

This position will work in both an office and a laboratory setting. When in the lab, there may be a risk of exposure to hazardous or biological waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning, and/or disposal of contaminated areas and waste.

Iovance Biotherapeutics Inc is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

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