Analytical Sciences and Technology Specialist II

The Analytical Sciences & Technology Specialist I participates in laboratory activities to support process development, support the development, qualification, and validation of analytical methods, perform product characterization for TIL therapies, and support critical reagent/materials selection, qualification, and testing programs. In this role, you will be involved in assay qualification, validation, optimization, standardization, and transfer of analytical and/or microbiological methods. Under reasonable supervision, you will support assay development experiments, carefully document methods and materials, assist with drafting SOPs/reports, and communicate findings. The ideal candidate demonstrates foundational skills and knowledge in process and analytical development and is excited to take on new challenges in a fast-paced and dynamic environment.

Essential Functions and Responsibilities

• Support the development of analytical and/or microbiological methods involving a variety of protocols and techniques.
• Make detailed observations and record them in a timely and relevant fashion.
• Performs assays for process assessment and characterization.
• Assist with analysis and interpretation of experimental results.
• Organize results for team presentation and discussion.
• Assist with drafting test methods, technical protocols and reports, and standard operating procedures (SOPs).
• Sets up, monitors, samples, and analyzes cell culture processes.
• Work with various internal teams to better understand the analytical methods for characterizing product critical quality attributes.
• Supports Quality Control group by performing training, support testing, and validation execution.
• Ensure training is up to date on new processes and analytical methods.
• Compliance and maintenance of lab safety, environment, and quality.
• Perform duties and responsibilities with proficiency and conformance to internal standard operating procedures and international governing procedures and standards.
• Familiar with ICH and FDA guidance and USP standards.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

• Minimum of 2 years of related experience with a bachelor’s degree, or an advanced degree without experience; or equivalent work experience.
• Hands-on cell culture and associated lab experience.
• Experience with microbiological techniques such as microscopy (gram stain) and growth promotion
• Proficiency in Microsoft Office Suite and spreadsheet programs required.
• Proficiency in graphing and statistical software.
• Must comprehend regulations and guidance documents and apply critical thinking. Skills to evaluate requirements and effectively communicate (written and oral) findings.
• Strong interpersonal, written, and oral communication skills are required.
• Must be organized, multitask, and be a team player.
• Comfortable working in an agile environment and adjusting priorities as needed.

Preferred Education, Skills, and Knowledge

• Foundation in experimental documentation, fundamental statistical analysis, and data presentation
• Experience with sterility testing, endotoxin testing, mycoplasma testing.
• Basic skills in molecular techniques, including qPCR or ddPCR.
• Experience with drafting SOPs and forms
• Exposure to assay development, cell product release testing, characterization studies, or design of experiment (DoE) approaches preferred., * 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 and perform repetitious actions such as pinching with the thumb and forefinger, turning with the hand/ arm, and reaching 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

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.