Overview

The Manager, Analytical Development will lead projects that focus on the development, qualification, validation, verification and comparability of analytical assays and processes for Clinical Trials and Commercial supply. This position will support cellular manufacturing, analytical development, process development, technology transfer activities as well as release and stability testing for early phase products related to Tumor Infiltrating Lymphocyte (TIL) and protein therapeutics clinical trials for the treatment of solid tumors sponsored by Iovance Biotherapeutics. Experience in developing pre-clinical packages for IND submission for cell and gene therapy products is required.

Specific Responsibilities:

• Lead and provide scientific oversight of bioanalytical studies and the qualification, validation or verification and comparability of assays involving a variety of protocols and techniques.
• 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 study design for analytical runs, data analysis, as well as culmination of data for peer review.
• Provide project management oversight of and demonstrate ability to troubleshoot external contracts for analytical method development, release, stability and critical reagent generation and testing.
• Author and review SOPs, protocols and associated reports per Good Documentation Practices (GDP) and quality standards.
• Maintain high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned

Education and Qualifications:

• PhD with 2 years of industry experience, MS 5 years industry experience or BS with 7 years of industry experience in Cell and Gene Therapy with a focus in Genetics/Immunology/Molecular Biology field.
• Possess a solid understanding of verification and validation of assays supporting clinical and commercial release of drug product as well as stability testing per appropriate regulatory guidance and standards.
• Quality control and/or GMP experience is required.
•  Prior experience developing and supporting cell and or gene therapy drug products. Understanding of regulations and guideline documents (cGMP / ICH / pharmacopeia) required.

• Ability to apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.
• Prior experience with project management tools demonstrating effective communication and documentation skills, tracking to timelines and milestones in scope and on budget.
• Must be capable of working in fast-paced, collaborative environment and manage multiple concurrent projects with a high degree of independence.
• Strong interpersonal, written, and oral communication skills are required.
• Must be organized, be able to multi-task, and be a team player.

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