Senior Manager, Raw Materials

Senior Manager, Raw Materials 🌿
Location: Bridgewater, NJ
Type: Full-Time / On-Site

Join Cellares, a pioneering Integrated Development and Manufacturing Organization (IDMO), as a Senior Manager, Raw Materials within our Quality group. You will play a crucial role in advancing our state-of-the-art cell therapy manufacturing platform!

Key Responsibilities:

🔍 Develop and oversee the Raw Materials testing program to ensure quality, identity, purity, and contamination compliance with GMP standards.
📜 Create, revise, and implement Standard Operating Procedures (SOPs) for sampling and raw material testing to meet regulatory requirements.
⚙️ Engage in qualification and validation for new raw materials, focusing on method development and optimization.
🤝 Collaborate with Supply Chain, Warehouse, and Quality Assurance to manage raw material receipt, inspection, and release.
📊 Coordinate with third-party laboratories for outsourced raw material testing and ensure prompt result reporting.
📝 Maintain meticulous records of raw material testing and support timely material releases within QC and MFG departments.
🔧 Investigate and resolve Out of Specification (OOS) results and other deviations.
💼 Train and mentor QC staff on raw material testing procedures.
✨ Champion continuous improvement initiatives to enhance raw material testing processes while ensuring regulatory compliance.
🤔 Collaborate to troubleshoot issues related to raw materials or testing procedures.
📚 Maintain training records and support internal assessments and audits as required.
📈 Provide Quality Control data for regulatory submissions.
⚙️ Support Quality Systems including change control, deviation, CAPA, audits, and quality metrics.
📝 Perform other duties as assigned.

Requirements:

🎓 BA or B.S. in a science discipline or comparable experience.
🔟 10+ years in cGMP or cGxP; 5+ years focused on raw material testing in pharmaceutical/biotech preferred.
📋 Strong knowledge of cGMP compliance and regulatory requirements.
🤝 Ability to work independently and as part of a team.
⏳ Effective time management skills.
🗣️ Excellent verbal, written, interpersonal, and organizational skills.
🤔 Self-aware, with integrity, authenticity, and a growth mindset.

Compensation: 💵 $90,000 - $210,000/year
Cellares offers a competitive compensation package, including subsidized Medical, Dental, and Vision Plans, 401(k) Matching, onsite lunches, and stock options.

At Cellares, we are committed to revolutionizing cell therapy manufacturing and expanding access to life-saving treatments worldwide. Are you ready to make an impact?

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Join us in creating the future of healthcare! 🚀