Iovance Biotherapeutics, Inc. · 1 day ago
Senior MSAT Specialist
Philadelphia, PA
Full-time
Onsite
Senior Level
5+ years expIovance Biotherapeutics is a company focused on cell therapy, and they are seeking a Senior MSAT Specialist to serve as a subject matter expert in Manufacturing Operations. The role involves data analysis, technical oversight of manufacturing processes, and authoring essential documentation while ensuring compliance with quality systems and continuous process improvements.
BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings
Serve as primary MSAT POC for study, clinical, and commercial manufacturing execution escalations for multiple cell and gene therapy GMP Processes
Perform Person-In-Plant (PIP) responsibilities at CMOs managing production execution at external manufacturing facilities
Ensure alignment of manufacturing practices at all manufacturing facilities
Provide MSAT oversight, training, and support within the manufacturing cleanroom environment as well as assist with onboard training of new MSAT 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 as part of process tech transfer as needed
Senior MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation: Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (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, MSAT MBRs
Senior Specialists will be responsible for managing MSAT 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 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
Qualification
Required
S degree in a relevant discipline or equivalent industry experience
A minimum of 5 years 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, 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
Preferred
Prior cell therapy experience is highly preferred
Company
Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.
501-1000 employees
H1B Sponsorship
Iovance Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (11)
2023 (7)
2022 (7)
2021 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.58B2024-02-20Post Ipo Equity· $211M
2023-07-10Post Ipo Equity· $150M
2020-05-27Post Ipo Equity· $603.7M
Leadership Team
Jean-Marc Bellemin
Chief Financial Officer
Cheryl Aranda
Executive Assistant to Chief Medical Officer
Recent News
2025-12-29
2025-12-07
2025-11-11
Company data provided by crunchbase