MSAT Specialist

Overview

The MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning steps of the manufacturing process tech transfer. The MSAT Specialist is also responsible for protocol and report authoring, oversight of manufacturing operations, and execution of MSAT laboratory activities.

Essential Functions and Responsibilities

• Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings.
• Serve as MSAT POC for clinical manufacturing execution escalations for cell and gene therapy GMP Processes. Perform Person-In-Plant (PIP) responsibilities at CMOs observing production and providing real time feedback and support during execution cell therapy batches.
• Observe and provide feedback of manufacturing operations, ensure alignment of manufacturing practices across multiple manufacturing facilities.
• Provide MSAT oversight, training, and support within the manufacturing cleanroom environment.
• Execute Technology Transfer responsibilities related to new product introduction or process improvements to internal and external manufacturing facilities. Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer, as needed.
• The MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:
• Quality Systems (minor to complex) – Change Controls, Deviations, CAPAs, Action Items
• Minor Study or investigational protocols and corresponding reports
• Process Characterization, Validation, Qualification protocols and report amendments
• Product Impact and Risk Assessments, Failure Modes Risk Analysis
• SOPs, COPs, MSAT MBRs
• MSAT Specialists will be involved in execution of investigation activities which may include execution of studies, GEMBA, Kaizen, Risk Analysis etc.
• 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.
• Execute hands on experiments in the MSAT 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

• B.S degree in a relevant discipline or equivalent industry experience.
• A minimum of 1 year of 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.
• Knowledge and understanding of GMP systems within a manufacturing facility.
• Ability to organize and analyze manufacturing process data.
• Knowledge of manufacturing process tech transfer.
• 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.
• 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 an accommodation.

Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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.