Manufacturing Team Lead

Advanced Therapies, LLC; Philadelphia (Philadelphia County); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing seeks a Lead Manufacturing Associate to oversee aseptic techniques and support the production of cutting-edge Cell & Gene Therapy products. This role requires a blend of technical expertise and leadership skills, as you'll be responsible for training staff, ensuring compliance with Good Manufacturing Practices, and driving continuous improvement in manufacturing processes. If you have a passion for biotechnology and a commitment to excellence, this is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• 8+ years of experience in manufacturing with a focus on aseptic techniques.
• Strong background in cell and gene therapy processes and regulations.

Responsibilities

• Oversee aseptic techniques and ensure compliance with standards.
• Train and mentor staff in aseptic operations and manufacturing processes.

Skills

Aseptic Technique

Technical Knowledge in Cell & Gene Therapy

Equipment Maintenance

GMP Concepts

Data Analysis

Training and Mentoring

Education

High School Diploma

Associate's Degree

Bachelor's Degree in Science

Tools

LIMS

Job description

Get AI-powered advice on this job and more exclusive features.

About the Role

The Lead Manufacturing Associate is responsible for the manufacture of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities

1. Understand aseptic technique concepts.
2. Oversee and monitor the overall performance of aseptic techniques, ensuring compliance with standards.
3. Perform aseptic techniques, identify unacceptable practices, and make spot corrections.
4. Explain the ‘why’ behind acceptable and unacceptable aseptic practices.
5. Train, coach, and mentor others in basic aseptic operations such as media preparation, thawing, passage, and harvesting.
6. Identify gaps and opportunities in aseptic techniques and implement improvements.
7. Operate and maintain equipment, including understanding maintenance requirements and troubleshooting complex issues.
8. Support sourcing and purchasing of equipment.
9. Prepare solutions and materials, analyze results, and resolve issues.
10. Possess technical knowledge in pharmaceutical and biotechnology industries, especially in cell and gene therapy.
11. Apply basic engineering and mechanical knowledge in manufacturing.
12. Participate in facility start-ups and lead subteams as needed.
13. Participate in technical transfer activities and provide feedback on facility fit.
14. Apply GMP concepts, recommend improvements, and support validation activities.
15. Manage materials, including procurement, documentation, and discrepancy resolution.
16. Use support systems (e.g., LIMS) proficiently and serve as SME or Super user.
17. Contribute to system design and improvement teams.
18. Oversee and monitor manufacturing processes, ensuring compliance and continuous improvement.
19. Train and mentor others in operations and systems.
20. Identify process gaps, implement improvements, and analyze scientific and process data.
21. Communicate data and process insights to stakeholders and ensure regulatory compliance.
22. Develop, review, and improve SOPs and batch records.
23. Participate in audits and inspections as SME.
24. Cross-train in other areas and work independently on complex tasks.
25. Lead and oversee manufacturing processes.

Requirements

High School diploma with over 8 years of relevant experience OR an Associate’s/Bachelor’s degree (science preferred) with over 5 years of relevant or equivalent experience.

Additional Details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Manufacturing
• Industry: Pharmaceutical Manufacturing