Senior Manufacturing Associate

Job Summary

Job Summary: We are looking for a highly motivated, experienced Senior Manufacturing Associate to join our team and create a world-class manufacturing organization. Working closely with the executive management team, the Senior Manufacturing Associate will be responsible for developing and performing manufacturing processes for RUO and IVD-labeled reagents and assay kits, identifying opportunities for process improvements and enabling the introduction of new products and processes.

The Senior Manufacturing Associate must be proficient in Good Manufacturing Processes (including but not limited to 21 CFR 820 and ISO 13485:2016 compliance).

• Plan, develop, and perform manufacturing operations for development and production-level materials, including but not limited to aliquoting, filling, capping, labelling, and final kit assembly.
• Document all manufacturing activities accurately in batch records in accordance with Good Manufacturing Practices (GMPs) and Good Documentation Practices.
• Develop & implement lean manufacturing techniques to improve Quality, Cost and Delivery of products.
• Develop robust manufacturing techniques for consistent, high-quality production.
• Assist in authoring or revising SOPs, work instructions, and process documentation. Write effective manufacturing documents and production records (Work Instructions, SOP’s, Batch Records).
• Represent the new product development core teams and support with all required documentation in accordance with design controls requirements.
• Support design transfers and develop product manufacturing plans as well as scale up (where applicable).
• Identify and escalate deviations or non-conformances; participate in root cause analysis and implement corrective actions (CAPA).
• Collaborate cross-functionally with Quality Assurance, R&D, and other departments to support continuous improvement and production efficiency.
• Maintain compliance with safety, environmental, and company policies.
• Participate in internal and external audits as a subject matter expert (SME) on manufacturing processes.
• Manage manufacturing laboratories and own all the calibration, maintenance, and repair activities for manufacturing lab equipment.
• Provide manufacturing vendor selection, qualification, and monitoring support.
• Develop & maintain production schedules to support R&D product launch schedules and growth of existing product sales.
• Schedule & complete periodic cycle counts of raw materials and finished goods.
• Write and execute protocols for qualification and validation of new and existing manufacturing processes, instrumentation, and general lab equipment.
• Train new associates.
• Lead and perform troubleshooting & support activities.

• Strong working knowledge of Microbiology/Molecular Biology and Chemistry, especially PCR.
• Experience working within regulated environments (FDA, IVD, RUO/LDT, ISO, etc.).
• Experience with lean manufacturing principles and reagent manufacturing.
• Experience with ERP and Quality Management Systems for material resource planning, work orders, inventory management and batch records is required.
• Bachelor of Science degree or equivalent.
• 4-6 years of experience in IVD reagent manufacturing.
• Lifting/pushing/pulling and carrying products weighing up to 45 pounds.

• Experience in production planning in an ERP system.
• Strong technical writing and presentations skills.
• Strong customer-service orientation, eager to meet expectations of both external and internal customers.

• Strong commitment to the team.
• Excellent communication skills.
• Flexible.
• Reliable and responsible.