Scientist I, Analytical Development

1 week ago

Tampa, Florida, 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. The successful candidate will be responsible for leading and supporting the analytical development potency assay qualification and GXP early-stage assay development projects.

Key Responsibilities
  • Provide scientific input for the design of cell-mediated immunoassays (CMI) regulated studies.
  • Responsible for assay format selection based on risk assessment and fit-for-purpose.
  • Responsible for method development, qualification/validation, troubleshooting, and sample analysis.
  • Assess and implement new technologies for CMI assays.
  • Serve as an internal subject matter expert on developed assays, providing technical support to internal and external laboratories working to implement assays.
  • Ensure assays are developed and executed per applicable guidance and regulations.
  • Contribute to assay protocol and qualification/validation report preparation.
  • Address quality assurance (QA) findings and observations.
  • Contribute to regulatory filings pertaining to assay details as needed.
  • Ability to independently analyze and interpret experimental data and to present and communicate results effectively to stakeholders and within a multi-disciplinary team environment.
  • Collaborate with Quality Control and ASaT teams to enable effective assay transfer, enabling clinical product development and manufacturing required support.
  • Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required, and data collection.
  • Maintain up-to-date training and knowledge on automation and analytical tools/equipment.
  • Perform robust analysis and statistical data evaluation for results-driven presentation and cross-functional discussion.
  • Contribute to scientific publications and the identification of patentable inventions.
  • Maintain a high level of professional expertise by regularly consulting scientific literature and attending training and/or scientific seminars.
  • Ensure compliance and maintenance of lab safety, environment, and quality.
  • Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.
Requirements
  • PhD with 2+ years of industry experience or master's degree with 5 + years of industry in the Immunology, Cellular, and Molecular Biology field.
  • Experience with immunology assays such as ELISA and multiplexed ligand binding assays (LBA) on Meso Scale Discovery and/or Ella platforms.
  • Proficient knowledge of GMP or Quality regarding 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 as required.
  • 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 that the data are accurate, logical, and consistent with internal and regulatory reporting requirements are required.
  • Able to work in a fast-paced, collaborative environment and manage multiple concurrent projects with high independence.
  • Strong interpersonal, written, and oral communication skills are required.
  • Must be organized, be able to multi-task, and be a team player.
Preferred Qualifications
  • Experience with multi-color flow cytometry analytical methods and familiarity with BD FACSLyric is preferred.

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