Scientist II, Analytical Development

Overview

The Scientist II will lead and support analytical development assay qualification and GXP early-stage assay development projects. This role requires relevant experience in analytical method development under the GMP and ICH guidelines. The scientist will have expertise in designing developing executing and analyzing molecular and cellular assays to characterize the function and potency of modified gene cellular products. In addition they are expected to be highly proficient and have subject matter expertise in cancer immunology and/or molecular and genetic level interrogation. The scientist will be responsible for timely planning documentation execution and reporting to facilitate the analytical goals. Experience is required in developing pre-clinical packages for IND submission for cell and gene therapy products.

Essential Functions and Responsibilities:

• Lead and provide scientific oversight of analytical strategies and studies for the evaluation of identity and potency attributes of cell therapy and protein drug products drug substances and process intermediates including assay format selection based on risk-assessment and fit-for-purpose.
• Lead and execute method development qualification troubleshooting and sample analysis by QbD approach.Ensure assays are developed and executed by applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address quality assurance (QA) findings and observations.
• Subject matter expertise in developing and performing analytical methods and data analysis of release and characterizing assays. Independently employ analytical strategy for the assessment of the genetic modification of human T cells and receptors.
• Subject matter expertise in developing and performing analytical methods and data analysis of assays including for genome integrity genotyping for allelic KO WGS NGS viral copy protein expression gene expression immunophenotyping ligand-binding cytotoxicity.
• Lead train and mentor small technically focused group of associates and junior scientists.
• Provide technical leadership and scheduling for the team to ensure deliverables coordination of external testing required and data protocols and associated reports per Good Documentation Practices (GDP). Compile data packages reports and author/review sections for regulatory filings.
• Lead train and mentor small technically focused group of associates and junior scientists. Provide technical leadership and scheduling for the team to ensure deliverables coordination of external testing required and data collection.
• Provide project updates on execution to timelines and resource allocation requests. Demonstrate professional-level presentation and communication skills in providing summaries of complex analysis of data sets to Senior level staff.
• Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars. Investigate and develop new methods and technologies necessary for project advancement. Help identify patentable inventions. Contribute to scientific presentations and publications.
• Ensure training is up to date on new processes and analytical methods. Ensure compliance and maintenance of lab safety environment and quality. Comply with Safety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations.
• Adhere to Iovance Biotherapeutics core values policies procedures and business ethics.

Travel < 20% of the time

Required Education Skills and Knowledge:

Ph.D. with 3 years of industry experience or masters degree with 10 years of industry in the Immunology Cellular and Molecular Biology field.

GMP or Quality experience with proficiency with 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.

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 that the data are accurate logical and consistent with internal and regulatory reporting requirements are required.

Must be capable of working in a fast-paced collaborative environment and managing multiple concurrent projects with high independence.

Strong interpersonal written and oral communication skills are required.

Must be organized able to multi-task and be a team player.

Preferred Education Skills and Knowledge:

• Experience with supporting clinical and commercial cell or gene therapy drug product manufacturing is preferred.
  

Physical Demands and Activities Required:

• Must be able to move to and from the office to the lab located on separate floors and move about the office and lab as needed.
• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to grasp with both hands perform repetitious actions such as pinch with thumb and forefinger turn with hand/ arm and reach above shoulder height.
  
• Must be able to use several types of laboratory equipment and pipettes for extended periods.
• Must be able to work on a tablet or computer typing for 50% of a typical working day.
• Must be able to move and lift 20 pounds multiple times daily.
• Must be able to use near vision to view samples at close range.
• Wear proper personal protective equipment when in a laboratory setting i.e. safety glasses lab coats and closed-toed shoes.

Mental: Clear and conceptual thinking ability; excellent judgment troubleshooting problem-solving analysis and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

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.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance 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 individuals 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. If you need assistance or accommodation to apply to one of our opportunities please contact .

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