Senior Specialist, Quality Control Lab Technical Support - Analytical jobs in United States
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Iovance Biotherapeutics, Inc. · 1 month ago

Senior Specialist, Quality Control Lab Technical Support - Analytical

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Senior Quality Control Analyst, Lab Technical Support-Analytical will support flow cytometry and potency method qualification/validation, method technical transfer, and product release testing at Iovance’s integrated Cell Therapy Center (iCTC).

BiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

Responsibilities

Collaborate effectively with the Iovance Analytical Development (AD) and Analytical Sciences and Technology (ASAT) departments to perform assay qualification, validation, and technical transfer of updated and new methods
Act as subject matter expert (SME) and train laboratory personnel on new and revised methods
As needed to support product release, perform GMP laboratory testing with minimal to no errors, while ensuring testing is completed and documented in compliance with all applicable procedures, standards, and GMP/GDP regulations
Author, review, and approve technical documents including but not limited to protocols, reports, and SOPs
Contribute ideas for process improvements and technology enhancements in the QC laboratories
Support thorough GMP investigations for quality events (e.g. deviations, invalid assays, OOS)
Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls
Perform technical review of laboratory data and logbooks
Support Health Authority inspections
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations
Other responsibilities as assigned

Qualification

GMP experienceMulticolor flow cytometryCell-based potencyCell cultureTechnical writingMicrosoft OfficeDetail-orientedProblem-solvingTeam collaboration

Required

Degree in Biology, Immunology, Microbiology, Molecular & Cell Biology, or related scientific field, with 8+ (Bachelor's), 6+ (Master's) or 3+ (Ph.D.) years of relevant experience
Minimum of three (3) years of GMP experience in the pharmaceutical industry within Quality Control or related function (e.g. AD or ASAT)
Solid understanding, functional knowledge, and hands-on experience with two (2) or more of the following: multicolor flow cytometry, cell-based potency, or cell culture with cell enumeration (NC-200)
Experienced technical writer (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls)
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
Successfully interface with multi-disciplined teams
Operate at a consistent and high level of efficiency, producing high quality and accurate results
Extremely detail-oriented with strong technical laboratory skills
High level of ownership and accountability
Demonstrate sense of urgency; ability to recognize time sensitivity
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics

Preferred

Experience with cell therapy products

Company

Iovance Biotherapeutics, Inc.

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Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer.

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 Company
Total Funding
$1.58B
2024-02-20Post Ipo Equity· $211M
2023-07-10Post Ipo Equity· $150M
2020-05-27Post Ipo Equity· $603.7M

Leadership Team

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Jean-Marc Bellemin
Chief Financial Officer
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Cheryl Aranda
Executive Assistant to Chief Medical Officer
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Company data provided by crunchbase