Analytical Development Associate II [Contract to Hire]

Overview

The Analytical Development Associate participates in laboratory activities to support process development, develop, qualify, and validate new analytical methods, perform product characterization for TIL therapies, and support critical reagent/materials selection, qualification, and testing program. In this role, you will be involved in assay optimization, qualification, and transfer analytical methods. Under reasonable supervision, you will perform assay development experiments, carefully document methods and materials, write SOPs/reports, and communicate findings. The ideal candidate has a proven track record of innovation, demonstrates a skill set 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 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.
• Analyze and interpret experimental results.
• Organize results for team presentation and discussion.
• Co-authors 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.

Required Education, Skills, and Knowledge

• Typically requires a minimum of 5 years of related experience with a bachelor’s degree, or 3 years and a master’s degree, or a PhD without experience, or equivalent work experience.
• Hands-on cell culture and associated lab experience.
• 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, able to 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
• Exposure in vitro T cell functional assays (potency, cytotoxicity, ELISA, proliferation, Luminex)
• Basic skills in molecular techniques, including qPCR or ddPCR.
• Basic skills in flow cytometry.
• Experience with drafting SOPs and forms
• Develops assays for cell product release and characterization by designing and executing studies via the design of experiment (DoE)

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 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

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.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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