Process Technical Services Specialist I

Overview

Schedule and Hours; Monday to Friday from 8am-5pm.

Occasionally weekend/ holiday work might be required.

Essential Functions and Responsibilities

• Serve as a manufacturing process technical SME representing Process Technical Services (PTS) during cross functional meetings.
• Serve as primary PTS point of contact for study, clinical and commercial manufacturing execution escalations for multiple cell and gene therapy GMP processes.
• Manage and own FMEAs, Change Controls, Deviations, Manufacturing Investigations, CAPAs, Action Items (management and execution).
• Manage and own study or investigational protocols, process characterizations, validations, qualification protocols as well as their corresponding reports.
• Writing product impact assessments, risk assessments and perform failure mode risk analyses.
• Assist with investigations, which may include Data mining, Execution of studies, GEMBA, and Kaizen.
• Assist with Technology Transfer campaigns of new product introduction, and process improvements to internal and external manufacturing facilities.
• Update SOPs and MBRs.
• Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements.
• Analyze and interpret manufacturing process data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment.
• Provide Training to manufacturing and PTS operators as needed for new processes and equipment.
• Execute hands on experiments in the iMAPs lab (as applicable).
• 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

• Up to 10% travel may be required.

Required Education, Skills, and Knowledge

• BS degree in a relevant discipline with a minimum of 2 years of relevant hands-on operations experience for clinical or commercial production and/or process development experience in the life sciences industry OR M.S degree in a relevant discipline.
• Expertise in cell culture and aseptic technique.
• Knowledge and understanding of GMP systems within a manufacturing facility.
• Ability to organize and analyze manufacturing process data.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to work cross functionally within the organization as part of a project team.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Preferred Education, Skills, and Knowledge

• Prior cell therapy experience is highly preferred.
• Knowledge of manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is preferred.

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 accommodation.

Physical Demands and Activities Required

• 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. Must be able to lift 20 pounds multiple times a day.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. Additionally, applicant must be able to use near vision to view samples at close range. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• 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 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 move to and from the office to the lab located on separate floors and move about the office and lab as needed.
• Wear proper personal protective equipment when in a laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.
• 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.

#LI-onsite