Manufacturing Operations Manager / Biopharmaceutical Manufacturing Manager

🌟 We're Hiring : Manufacturing Operations Manager! 🌟

Join our mission-driven team to lead and optimize manufacturing operations for cutting-edge autologous cell therapy production. We are looking for an experienced Manufacturing Operations Manager to oversee startup and clinical manufacturing and spearhead the initial plan for commercial-scale production.

📍 Location : Philadelphia, United States

⏰ Work Mode : Work From Office

💼 Role : Manufacturing Operations Manager

What You'll Do :

🚀 Lead the Manufacturing Operations team to meet monthly and quarterly production goals

📅 Develop efficient manufacturing schedules and ensure optimal resource utilization

🔍 Lead critical investigations, approve deviations, non-conformances, and CAPAs in partnership with Quality

📈 Identify and drive continuous improvement initiatives to boost operational efficiency and effectiveness

📊 Utilize visual management tools, KPIs, and huddle boards to maintain operational excellence

📑 Ensure timely closure of batch records and SOPs to support smooth batch releases

🤝 Coordinate closely with Quality Release and Supply Chain teams in a just-in-time manufacturing environment

What We're Looking For :

✅ 5-10 years in GMP biopharmaceutical manufacturing operations, with strong cell culture and downstream processing experience

✅ 3+ years in a leadership or supervisory role managing manufacturing teams

✅ Deep understanding of aseptic gowning, ISO Class 5 cleanroom operations, and cell / gene therapy manufacturing

✅ Quality-focused mindset, familiar with 21 CFR Part 11, GxP best practices, and FDA regulations

✅ Proven ability to lead investigations and manage compliance activities with regulatory rigor

Ready to make an impact? 🚀 Apply now and let's grow together!