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.
Overview
The Senior Process Technical Services Specialist is a senior-level manufacturing operations subject matter expert responsible for technical leadership across cell therapy manufacturing processes. This role contributes deep expertise in aseptic technique, laboratory execution, and process science, and is responsible for leading technology transfer activities, supporting complex investigations, driving process improvements, and providing ongoing technical support for manufacturing operations. The Senior PTS Specialist also authors and supports protocols and reports, mentors junior staff, and partners cross-functionally to ensure robust process performance across small-scale and full-scale manufacturing.
Essential Functions and Responsibilities
- Subject matter expert in aseptic technique, laboratory execution, and cell therapy manufacturing processes, representing PTS in cross-functional meetings and technical discussions.
- Lead technology transfer activities to and from internal and external manufacturing facilities, including process implementation, process translation, training support, and cross-site technical support.
- Own and project manage major change controls, including those associated with regulatory actions, and lead process hyper care to determine whether additional CAPAs or change controls are required.
- Lead investigation teams and support the initiation and execution of complex manufacturing and process improvement investigations, including completion of minor and major deviations, creation of risk assessments, and execution of related study activities as needed.
- Author, review, approve, and support technical documentation as delegated, including protocols, reports, risk assessments, manufacturing support documents, and quality system records.
- Drive continuous improvement by leading GEMBA walks, identifying process improvement opportunities, and spearheading implementation of approved improvements.
- Analyze and interpret process data using statistical tools such as Minitab and JMP to support troubleshooting, process monitoring, trend evaluation, and data-driven decision-making.
- Train and mentor staff as a process SME, support junior staff with protocol and report development, and provide guidance on most or all process-related topics.
- Provide audit and inspection support as a process SME and serve as a functional reviewer and approver for delegated documents.
- Support manufacturing activities across small-scale and full-scale operations and perform other duties as required to meet departmental and business needs.
- Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations / LIRs (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution)
- Study or investigational protocols and corresponding reports
- Process Characterization, Validation, Qualification protocols and reports
- Product Impact and Risk Assessments, Failure Modes Risk Analysis
- Senior Specialists will be responsible for managing PTS department Quality System metrics and managing complex investigations (CAPA, Deviation, etc.) related to the manufacturing process. Investigation activities may include execution of studies, GEMBA, Kaizen, Risk Analysis, etc. through to completion.
- 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 and ensure process trends are addressed appropriately. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment.
- 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.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline or equivalent industry experience.
- Requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years with a Master’s degree; or a PhD with 3 years of experience; or equivalent experience.
- Subject matter expertise in aseptic technique and laboratory execution.
- Previous cell therapy manufacturing process experience required.
- Understanding of both small-scale and full-scale manufacturing.
- Knowledge and understanding of GMP systems within a manufacturing facility.
- Experience with manufacturing process technology transfer and change control management.
- Ability to organize, analyze, and interpret manufacturing process data and identify opportunities for process improvement.
- Excellent oral and written communication skills with strong technical writing ability.
- Ability to work cross-functionally within the organization as part of a project team.
- Self-motivated and willing to accept temporary responsibilities outside of the initial job description.
- Must be comfortable in a fast-paced environment and able to adjust workload based on changing priorities.
Preferred Education, Skills, and Knowledge
- Complex understanding of cell biology and immunology.
- Previous TIL manufacturing experience preferred.
- Prior cell therapy experience is highly 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 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 [email protected].
