Senior Specialist, Quality Control Lab Technical Support - Analytical

Iovance Biotherapeutics Inc.•Philadelphia, PA

72d•Onsite

About The Position

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). This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200), cell-based potency methods utilizing various immunoassay platforms (ELISA, ELLA, etc.), and/or identity / characterization / potency methods using multicolor flow cytometry platforms. This position will support the onboarding of new, or updating of existing, methods for the QC analytical team for release testing of cell therapy products. You may be required to work occasional weekends and holidays to complete assigned work.

Requirements

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.

Nice To Haves

Experience with cell therapy products.

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.