Scientist I, Analytical Development - Potency

Overview

The Scientist is responsible for leading and supporting the analytical development potency assay qualification and GXP early-stage assay development projects. This role requires relevant experience in analytical method development following GMP and ICH guidelines and proficient technical training in functional cellular and ligand-binding potency assays. The scientist is expected to know and understand cancer immunology and T-cell activation. Additionally, the scientist will be responsible for planning, documenting, executing, and reporting to efficiently facilitate the analytical and process development goals. 

Essential Functions and 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.

Travel – 10% if needed

Required Education, Skills, and Knowledge

• 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 Education, Skills, and Knowledge

• Experience with multi-color flow cytometry analytical methods and familiarity with BD FACSLyric is preferred

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

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, such as safety glasses, lab coats, and closed-toed shoes, when in a laboratory setting.

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 change the position's responsibilities 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 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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