Supervisor, Quality Control, Raw Material 2nd Shift

ZipRecruiter; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative biopharmaceutical company is looking for a Quality Control Supervisor to oversee the QC Raw Material Program. This role involves managing sampling, release testing, and vendor qualifications within a dynamic team environment. You will ensure compliance with regulatory standards while driving continuous improvement initiatives. If you have a strong background in quality control within a GMP-regulated environment and are passionate about contributing to groundbreaking cancer therapies, this position offers a unique opportunity to make a significant impact in the field.

Qualifications

• Strong organizational skills and ability to manage multiple projects.
• Experience with raw material inspection/testing and leading quality events.

Responsibilities

• Manage daily raw material release operations, including sampling and testing.
• Lead investigations for out-of-specification results and corrective actions.

Skills

Microbiology

Potency Testing

Wet Chemistry

Gel Electrophoresis

FT-IR

UV/VIS

Titration

GC Methodologies

Team Management

Communication Skills

Education

Bachelor's Degree in Biological Sciences

5+ Years in GxP Regulated Setting

Tools

Data Management Systems

Laboratory Control Operations

Job description

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Supervisor in Raw Materials, responsible for overseeing the QC Raw Material Program at the iCTC site. The manager will handle sampling, release testing, data review, and vendor qualification for all raw material lots used in manufacturing at the iCTC site. Activities include chemical and biological raw materials, component inspection, and final packaging.

A good understanding of QC test methods and raw materials release requirements per USP and EP compendia is desired. Experience in a GMP-regulated environment is essential. The position reports to the Senior Manager, Quality Control Raw Materials.

2nd Shift: Monday - Friday 3:00pm - 11:30pm

Essential Functions and Responsibilities

1. Schedule and manage daily raw material release operations, including sampling, inspection, and testing.
2. Oversee and manage the QC raw material schedule in alignment with site demand.
3. Maintain and oversee the training program within QC Raw Materials.
4. Review and approve AQL, CO2 testing, and other raw material releases.
5. Ensure timely closure of quality events related to raw material and drug product releases.
6. Author, review, and approve SOPs, protocols, reports, and specifications.
7. Manage vendor qualification program for raw materials.
8. Serve as SME for QC raw materials.
9. Lead readiness efforts for regulatory inspections and audits.
10. Provide leadership and promote a positive team environment within QC Raw Materials.
11. Champion continuous improvement initiatives.
12. Coordinate release schedules with other departments.
13. Plan and execute assignments, participate in project planning.
14. Lead investigations for out-of-specification results and corrective actions.
15. Establish relationships with partners and oversee performance management processes.
16. Support technical problem solving related to raw materials testing and release.
17. Operate efficiently, ensuring high-quality results in a fast-paced environment.
18. Adhere to company values, policies, and ethics.
19. Supervise and oversee analysts.
20. Perform other duties as assigned.

Required Education, Skills, and Knowledge

1. Bachelor's degree in biological sciences or related field.
2. At least 5 years in a GxP regulated setting within pharmaceutical or biotech industries.
3. Experience managing teams is a plus.
4. Strong organizational skills and ability to manage multiple projects.
5. Technical expertise in microbiology, potency, gel electrophoresis, wet chemistry, FT-IR, UV/VIS, KF, Titration, GC methodologies.
6. Experience with raw material inspection/testing and leading quality events.
7. Familiarity with laboratory control operations, quality systems, and regulatory inspections.
8. Experience with method validation and data management systems.
9. Knowledge of biological drug development and external partner management.
10. Excellent communication skills and ability to handle multiple priorities.
11. Flexible, adaptable, and proactive problem solver.

Preferred Additional Experience

1. Experience with cell and/or gene therapy products.
2. Experience with change controls, risk assessments, validations.

Physical and Work Environment Requirements

Must wear PPE, stand/walk for most of the day, have near vision, and lift up to 25 pounds. Work in office and lab settings, including cleanrooms and biohazard areas, with potential exposure to noise, chemicals, and biohazards.

Management retains discretion to modify duties. Iovance values diversity and is an equal-opportunity employer. For accommodations, contact [e-mail].