Lead Quality Control Analyst
1 month ago
**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 include, but are not limited to, in-process, final drug product, and stability testing with a focus on cell therapy products. We 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.) and flow cytometry platforms. This position will support the ramp up of QC and other activities in a newly built facility for cell therapy products.
**Essential Functions and Responsibilities**
- Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with mínimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
- Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
- Perform all activities with respect to GMP/GDP compliance.
- Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
- Support thorough GMP investigations for out of specification test results and other quality events (initiate DRs and LIRs)
- Support technical problem solving for issues pertaining to GMP Quality Control
- Support product stability programs including execution of stability testing and stability data analysis
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Perform peer and/or technical review of laboratory data and logbooks
- Analysis of assay-specific analytical performance trending
- Support Health Authority inspections
- Provide input to functional laboratory and cross functional team meetings
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
- Other responsibilities as assigned
**Required Education, Skills, and Knowledge**
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
- Minimum three (3) years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus.
- Experience with Flow Cytometry and Cell based ELISA platforms
- 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.
**Preferred Education, Skills, and Knowledge**
- Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
**Physical Demands and Activities Required**:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 30 pounds.
**Mental**:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
**Work Environment**:
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
LI-onsite
-
Lead Quality Control Analyst
1 week ago
Philadelphia, United States Iovance Biotherapeutics Inc Full time**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**:U_pdated resume_ **We are Hiring! **We look forward to seeing you at the Job Fair.** **Overview** Iovance Biotherapeutics is...
-
Lead Quality Control Analyst
5 days 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 Analyst: Cell Therapy
1 month ago
Philadelphia, Pennsylvania, United States Proclinical Full timeQuality Control Analyst: Cell Therapy - Contract - OnsiteProclinical Staffing is seeking a Quality Control Analyst: Cell Therapy to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.Skills & Requirements:Bachelor's degree in a relevant discipline (biological sciences or equivalent).Minimum three (3) years of experience...
-
Quality Control Analyst II, Quality Control
5 days 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. OverviewIovance Biotherapeutics...
-
Quality Control Analyst
3 days ago
Philadelphia, United States NEUROVUE Full timeNEUROVUE is disrupting the Life Sciences consulting paradigm with a proprietary approach to talent attraction and retention. With focus and extensive investment, NEUROVUE has created an unparalleled employment experience that attracts industry top minds for our clients’ project needs. Through this innovative approach, clients rely upon NEUROVUE for...
-
Quality Control Analyst
2 days ago
Philadelphia, United States NEUROVUE Full timeNEUROVUE is disrupting the Life Sciences consulting paradigm with a proprietary approach to talent attraction and retention. With focus and extensive investment, NEUROVUE has created an unparalleled employment experience that attracts industry top minds for our clients’ project needs. Through this innovative approach, clients rely upon NEUROVUE for...
-
Supervisor, Quality Control Analyst
6 days 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 Manager
1 week ago
Philadelphia, United States Hiring Now! Full timeLocal Quality manager role with food manufacturer, My client is a SQF certified food manufacturer committed to producing high-quality meat and poultry products while maintaining the highest standards of safety and compliance. They are currently seeking an experienced Quality Control Manager to lead our Quality Control / Quality Assurance Department to new...
-
Senior Quality Control Analyst
2 weeks ago
Philadelphia, United States R&D Partners Full timeJob DescriptionJob DescriptionEssential Functions and ResponsibilitiesSupports Technology Transfer related to new validated assays or process improvements to internal and external laboratory facilities. Provide hands-on technical training to laboratory personnel as part of process tech transfer as needed.Supports Stability Program, data review, protocol and...
-
Quality Control Analyst II
5 days 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 Quality Control...
-
Quality Control Analyst I
5 days 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...
-
Quality Assurance Analyst
2 months ago
Philadelphia, Pennsylvania, United States IT Excel LLC Full timeJob Description The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software to user requirements. They ensure that the software functions according to those...
-
Quality Assurance Analyst
2 months ago
Philadelphia, United States IT Excel LLC Full timeJob Description -The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software to user requirements. They ensure that the software functions according to...
-
Philadelphia, United States Iovance Biotherapeutics Inc. Full timeIovance 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 resume We are Hiring! We look forward to seeing you at the Job Fair. Overview The Senior Director, Quality Control (QC) Microbiology, will lead the...
-
Supervisor, Quality Control
6 days 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,...
-
Philadelphia, United States Laguna Source Full timeThis is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for managing and ensuring the highest standards of Quality Control for life-saving therapies as well as supporting the ramp up of new QC labs, performing key QC lab techniques including ELISA assays and flow cytometry platforms....
-
Philadelphia, United States Laguna Source Full timeThis is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for managing and ensuring the highest standards of Quality Control for life-saving therapies as well as supporting the ramp up of new QC labs, performing key QC lab techniques including ELISA assays and flow cytometry platforms....
-
Data Warehouse Quality Assurance Analyst
3 days ago
Philadelphia, United States Philadelphia Streets Full time**Data Warehouse Quality Assurance Analyst** * 1601 Market St, Philadelphia, PA 19102, USA * Full-time **Company Description** Who We Are A best-in-class city that attracts best-in-class talent, Philadelphia is an incredible place to build a career. From our thriving arts scene and rich history to our culture of passion and grit, there are countless reasons...
-
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 Senior Director,...
-
Quality Control Intern
1 month ago
Philadelphia, United States Deitz & Watson,Inc. Full timeRequisition Number: 13469 Date Posted: 4/26/2024 Location: Dietz and Watson Production Address: 5701 Tacony Street City: Philadelphia State: PA Category: College Internships Description Quality Control Internship:Duration: Summer 2024 Location: Dietz Quality Control, Intern, Control, Manufacturing, Quality
