Overview

The Associate Scientist, Late-Stage Process Development will be responsible for supporting process development projects related to automation and technology transfer. The successful candidate will have cell culture experience and previous experience in process development or manufacturing support, and good knowledge of cGLP/cGMPs.

Essential Functions and Responsibilities:

• Lead/support process and analytical development experiments involving a variety of protocols and techniques.
• Design development and characterization studies with some autonomy. Write protocols, execute studies, analyze data, author reports, and orally present findings.
• Support technology transfer of automation process to internal and/or external manufacturing partner(s).
• Evaluate new technologies for automation to improve the process’s manufacturability within a closed system.
• Support manufacturing investigations, as needed.
• Make detailed observations and record them in a timely and relevant fashion.
• Provide support related to data and records management
• Ensure training is up to date on new processes and analytical methods.
• 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.

Required Education, Skills, and Knowledge:

• PhD in chemical engineering, immunology, biology, microbiology or related with 0-2 years of industry experience, or bachelor’s degree and 8 years of industry experience is required; or master’s degree with 6 years of industry experience.
• Proficiency in Microsoft Office Suite and spreadsheet programs required
• Proficiency in Graph Pad, MiniTab, and FACS DIVA software is desirable
• Must be able to 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, be able to multitask, and be a team player
• Role may require up to 10-15% travel, as needed.

Preferred Education, Skills, and Knowledge

• 2+ years of cell culture / cell therapy/biotechnology/life science industry experience preferred.
• Working knowledge with cell therapy process development is a plus.
• Previous experience with technology transfer (sending or receiving)
• Automation experience working with media preparation and stability studies
• Experience with cell therapy manufacturing equipment such as Miltenyi Prodigy, Lovo, G-Rex flasks, Cytiva’s or Thermo’s cell therapy processing train, CRFs is a plus.
• Analytical skills, such as flow cytometry or qPCR is a plus

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 wear appropriate Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must be able to work in a lab setting with biohazards / various chemicals.
• Able to stand and/or walk 70% (and sit 30%) within your scheduled workday, which may include climbing ladders or steps.

• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing up to 45 pounds.
• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.

• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects when not in a lab setting.
• Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information.

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 do not 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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