We have other current jobs related to this field that you can find below
-
Quality Control Laboratory Manager
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timePosition OverviewSalary: CompetitiveRole Summary:The Quality Control Laboratory Manager for Potency Assays is responsible for overseeing the quality control testing processes for cell-based potency assays at Iovance Biotherapeutics Inc. This role encompasses a range of testing operations, including in-process assessments, final product evaluations, and...
-
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: OverviewThe Quality Control Laboratory Manager, Potency Assays will manage quality control testing operations for cell-based potency assays at Iovance’s integrated Cell Therapy Center (iCTC). The QC Analytics testing operations include, but are not limited to, in-process and final drug product, and stability testing...
-
Manager, Quality Control Laboratory Potency Assays
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. OverviewThe Quality Control...
-
Senior Quality Control Analyst
1 month ago
Philadelphia, United States Planet Pharma Full timeWe are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.), flow cytometry platforms, as well as cell count/viability determinations using the NC-200 platform. This position will support the ramp up...
-
Senior Quality Control Analyst
1 month ago
Philadelphia, United States Planet Pharma Full timeWe are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.), flow cytometry platforms, as well as cell count/viability determinations using the NC-200 platform. This position will support the ramp up...
-
Quality Control Analytics Supervisor
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timePosition OverviewSalary: CompetitiveRole Summary:The Quality Control Analytics Supervisor is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics Inc. This role encompasses various testing operations, including in-process assessments, final product evaluations, and stability analyses for both clinical and...
-
Quality Control Analytics Supervisor
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition: Supervisor, Quality Control AnalyticsSalary: CompetitiveSummary: The Supervisor of Quality Control Analytics is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics. This role encompasses various testing activities, including in-process, final product, and stability assessments for both...
-
Supervisor, Quality Control Analytics
22 hours ago
Philadelphia, United States Planet Pharma Full timeThis role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Supervisor, Quality Control Analytics role will have direct oversight of the QC...
-
Supervisor, Quality Control Analytics
2 days ago
Philadelphia, United States Planet Pharma Full timeThis role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Supervisor, Quality Control Analytics role will have direct oversight of the QC...
-
Supervisor, Quality Control Analytics
3 weeks ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview The Supervisor, Quality Control Analytics role will support the Quality Control (QC) Analytics programs and testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The QC Analytics testing operations include but are not limited to, in-process, final drug product, and stability testing for...
-
Quality Control Analytics Supervisor
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timePosition OverviewSalary: CompetitiveSummary:The Quality Control Analytics Supervisor is responsible for overseeing the QC Analytics programs and testing operations at Iovance Biotherapeutics Inc. This role encompasses in-process, final product, and stability testing for both clinical and commercial batches. Candidates should possess hands-on experience in at...
-
Supervisor, Quality Control Analytics
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. Overview The Supervisor,...
-
Quality Control Training Analyst, Analytics
3 weeks ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Quality Control Training Specialist will support quality control training at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control training programs...
-
Lead Quality Control Analyst
3 weeks ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Quality Control Analyst will support quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs...
-
Lead Quality Control Analyst
2 days ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Quality Control Analyst will support quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs...
-
Quality Control Analyst I
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. OverviewThe Quality Control...
-
Lead Quality Control Analyst
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. Overview Iovance...
-
Quality Control Specialist
3 months ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house...
-
Senior Quality Control Specialist
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition Title: Lead Quality Control AnalystCompany: Iovance Biotherapeutics IncSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is an innovative, late-stage organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. The Lead Quality Control Analyst will play a pivotal role in overseeing...
-
Senior Quality Control Specialist
5 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition Title: Lead Quality Control AnalystCompany: Iovance Biotherapeutics IncSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is an innovative company at the forefront of developing and commercializing advanced cancer immunotherapies. We are seeking a dedicated Quality Control Analyst to enhance our quality control testing...
Manager, Quality Control Laboratory Potency Assays
1 month ago
Manager, Quality Control Laboratory Potency Assays
- Monday to Friday, first shift
- Comp target $135-140K, will have bonus and long term incentives
- Minimum of a Bachelor’s degree in Biology, Biochemistry, or related scientific field.
- Six (6) to eight (8) years of experience in the pharmaceutical industry within a Quality Control role with increasing project and management responsibilities; experience with cell therapy products is a plus.
Required Qualifications:
- GMP experience
- Management experience
- Potency experience
Technical Knowledge and Skills:
- Cell-Based Potency Assays (including ELISA platforms)
- Cell maintenance (primary cells and continuous cell lines)
- Cell count determination (NC 200)
- In-depth knowledge of ICH/USP/EMA guidelines in a GMP QC setting
- Proficient in technical writing (e.g., test methods, SOPs, protocols)
- Experience authoring quality documents (e.g., deviations, change controls, CAPAs, investigations)
- Familiarity with LabVantage LIMS
Overview
The Quality Control Laboratory Manager, Potency Assays will manage quality control testing operations for cell-based potency assays. The QC Analytics testing operations include, but are not limited to, in-process and final drug product, and stability testing for clinical and commercial lots. The role requires solid knowledge and a functional understanding, including hand-on testing, in the following areas: cell maintenance and cell count determination (NC-200) and cell-based potency assays using various immunoassays (ELISA, etc.) with a focus on cell therapy products. This position supports the ramp-up of QC Analytical release assays and other activities in a newly built facility for cell therapy products.
This role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Quality Control Laboratory Manager, Potency Assays role will have direct oversight of the QC Supervisors and analysts and assay performance. Overtime, weekends, and holiday work may be required to meet target turn-around times for product release.
Essential Functions and Responsibilities
- All duties are performed independently with minimal supervision and oversight.
- Act as technical subject matter expert (SME) for potency testing and related activities.
- Responsible for the scheduling and timely execution of potency testing and related activities and the respective data review and release.
- Manage the day-to-day GMP QC Potency testing activities at their facility including quality control testing and support testing for cell therapy intermediates, final product, and stability testing.
- To ensure target turn-around times are met, may be required to assist in execution of assays.
- Ensure that QC staff are appropriately trained and are performing tests in accordance with method procedures and are consistent with implementing the required techniques.
- Responsible for data analysis and final result reporting to support product lot release with adherence to turnaround times.
- Ensure that the daily GMP quality control laboratory testing activities at the facility are executed with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Lead/Support thorough GMP investigations for out of specification test results, corrective actions, and verification of effectiveness, and other quality events.
- Provide technical problem solving for issues pertaining to GMP quality control.
- Support product stability programs including timely scheduling of stability testing, stability data analysis, and final reporting of stability data.
- Responsible for the generation/revision and/or review of documentation, such as SOPs, protocols and reports, especially for potency assays.
- Responsible for ensuring timely review of laboratory data and logbooks in the potency laboratory space.
- Support LIMS initiative.
- Ensure trending of analytical performance is performed, as required.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Support Health Authority inspections.
- Organize and conduct Tier 1 and other QC-related meetings.
- Successfully interface and provide input with multi-disciplined teams.
- Ability to effectively manage multiple priorities involving dynamic and aggressive timelines at a high level of productivity.
- Other responsibilities, as assigned.
Education and Qualifications
- Minimum of a Bachelor’s degree in Biology, Biochemistry, or related scientific field.
- Six (6) to eight (8) years of experience in the pharmaceutical industry within a Quality Control role with increasing project and management responsibilities; experience with cell therapy products is a plus.
- Solid understanding and functional knowledge with hands-on experience with the following: Cell Based Potency Assays and supporting ELISA platforms and cell maintenance (primary cells and continuous cell lines) and cell count determination (NC 200)
- In-depth knowledge of ICH/USP/EMA guidelines in a GMP QC setting.
- Experience in managing and leading a team of scientific personnel.
- Highly proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
- Experience in authoring quality documents (e.g., deviations, change controls, CAPAs, investigations, etc.)
- Experience with laboratory information management systems, i.e., LabVantage LIMS.
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- 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)
