Iovance Biotherapeutics, Inc. · 1 month ago
Process Technical Services Specialist I
Philadelphia, PA
Full-time
Onsite
Entry, Mid Level
2+ years expIovance Biotherapeutics is focused on advancing cell and gene therapies, and they are seeking a Process Technical Services Specialist I to support manufacturing processes. The role involves serving as a technical SME, managing various manufacturing protocols, and ensuring compliance with GMP standards.
BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
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
Qualification
Required
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
Prior cell therapy experience is highly preferred
Knowledge of manufacturing process tech transfer
Involvement in prior manufacturing process tech transfer is 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