Senior Process Technical Services Specialist

Iovance Biotherapeutics • Philadelphia, PA

8h • Onsite

About The Position

The Senior PTS Specialist is a Manufacturing Operations cell therapy subject matter expert. The PTS Senior Specialist reports to the Manager, PTS and is responsible for contributing to deviation root cause analysis and owning steps of the manufacturing process of tech transfer. The Senior PTS Specialist is also responsible for protocol and report authoring, Co/lead tech transfer and ongoing technical support for manufacturing operations, and execution of PTS laboratory activities.

Requirements

• B.S degree in a relevant discipline or equivalent industry experience.
• a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience (relevant hands-on operations experience for clinical or commercial production and/or process development experience) in the life sciences industry.
• Expertise in cell culture and aseptic technique.
• Expertise in laboratory execution.
• Previous cell therapy manufacturing process experience required.
• Understanding small scale and full scale manufacturing.
• Knowledge and understanding of GMP systems within a manufacturing facility.
• Ability to organize, analyze manufacturing process data, and provide potential process improvements.
• Knowledge and expertise in manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is required.
• 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.

Nice To Haves

• Complex understanding of cell biology and immunology, previous TIL manufacturing experience preferred.
• Prior cell therapy experience is highly preferred.

Responsibilities

• Serve as a manufacturing processes technical SME representing PTS during cross functional meetings.
• Serve as a primary PTS point of contact for study, clinical and commercial manufacturing execution escalations for multiple cell and gene therapy GMP processes.
• Provide PTS oversight, training, and support as required within the manufacturing cleanroom environment as well as assist with onboard training of new PTS specialists.
• Manage and own Technology Transfer campaigns of new product introduction and process improvements to internal and external manufacturing facilities.
• Provide hands-on manufacturing process training to manufacturing personnel and development of training materials as part of process tech transfer as needed.
• Senior PTS Specialists may be responsible for the authoring, collaborating, approving and the ownership/management of the following documentation: 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, SOPs, COPs, PTS MBRs.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior