Worldwide recruitment company

Senior Reagent Manufacturing Associate   (Closed)

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Position

Senior Reagent Manufacturing Associate

About Our Client

• A global developer of molecular technologies and high multiplex real-time PCR assays.
• Their molecular diagnostic solutions can simultaneously detect multiple targets with high accuracy for infectious diseases, respiratory infections and STDs.

Job Summary

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

Job Description

• - Perform reagent manufacturing operations for development and production-level materials, including but not limited to aliquoting, filling, capping, labelling and final kit assembly.
• - Document all reagent manufacturing activities accurately in batch records in accordance with Good Manufacturing Practices (GMPs).
• - Write effective manufacturing documents and production records (Work Instructions, SOP’s, Batch Records).
• - Maintain production schedules to support R&D product launch schedules and growth of existing product sales.
• - Complete monthly, quarterly and annual cycle counts of raw materials and finished goods.
• - 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

Qualifications

• Minimum/Required Qualifications:
• - Experience working with infectious substances and with laboratory bio-safety level requirements.
• - Strong working knowledge of Microbiology/Molecular Biology and Chemistry, especially PCR.
• - Experience working within regulated environments (FDA, IVD, 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.
• - 3 years of experience in IVD reagent manufacturing.
• - Lifting/pushing/pulling and carrying products weighing up to 45 pounds.
• Additional/Preferred Qualifications/Competencies:
• - 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
• - Ability to work cross-functionally, including upstream and downstream for reagent manufacturing functions of filling, capping, labeling and finished kit assembly, including:
• - Pre-production planning and inventory management
• - Post- production picking, packing and shipping of finished goods to customers
• - Experience with commercial grade printers for product labeling

What's On Offer

• - 15days PTO, 6 sick days,
• - Travel Insurance, Health Insurance(Medical, Dental, Vision),
• - 401k(4%)
• - Relocation support

Apply online or feel free to contact us directly for more information about the opportunity. Due to the high volume of applicant, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.


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