As a PCR Production Chemist II, you will play a crucial role in producing specialized life science products that empower researchers and scientists to achieve healthcare breakthroughs and save lives. Your primary responsibilities will include performing bench chemistry processes, preparing bulk solutions and buffers, and conducting both final and in-process quality control testing.
You will collaborate regularly with internal and external stakeholders to drive continuous process improvement initiatives, investigate product-related issues, and develop effective solutions to manufacturing challenges. In this position, you will gain in-depth knowledge of the manufacturing process and stay informed about safety, environmental, and OSHA regulations to uphold our high standards and meet customer expectations.
Join our Global Supply Chain Manufacturing team, dedicated to delivering high-quality products that support clinical diagnostic labs and life sciences research.
How You’ll Make An Impact:
- Conduct bench chemistry processes in the lab, including bulk, buffer, and solution preparation, as well as final and in-process QC testing.
- Expand your expertise in quality control and manufacturing while contributing to healthcare products that enhance quality of life for millions.
- Impact value stream performance by documenting current processes and assisting in the implementation of improvement plans.
- Ensure the delivery of high-quality products by making process enhancements in compliance with safety, environmental, and OSHA regulations.
- Adhere to controlled Standard Operating Procedures (SOPs) and Production Procedures (PPs), meticulously documenting production in batch records according to GDP/GMP guidelines.
- Lead and train team members on the formulation of complex products.
- Develop departmental SOPs, work instructions, and deviation protocols, as well as initiate Quality Notifications for variances and non-conforming materials.
- Conduct Root Cause Analysis for Quality Notifications and recommend effective corrective actions.
- Execute Process Order transactions in SAP and review Production Order Variances.
What You Bring:
- Education: Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or a related material science discipline.
- Work Experience: 4 to 7 years of industry experience in biotechnology, with hands-on experience using lab and industrial equipment.
- Manufacturing Experience: Familiarity with GMP and ISO manufacturing environments.
- Skills: Excellent communication, interpersonal, and relationship management skills, with a strong desire to foster collaboration across organizations.
- Technical Proficiency: Experience with SAP or other ERP systems is preferred.
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