The Reagent Management Lead will focus on reagent management to ensure that sufficient qualified reagents for the laboratories of clinical and research operations. This position will be responsible for setting up reagent manufacturing procedure, QC preproduce, Supporting NGS assay development, reagent manufacturing automation development.

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  Provide technical leadership and support for reagents management and manufacturing for NGS lab and Covid lab.
• Lead in the development and revision of reagent manufacturing documentation like SOPs, batch records and material specifications.
• Ensure all operators/ manufacturing team members are proficiently trained on current and new procedures regarding manufacturing reagents, assembling kits, and qualification of assigned reagents, following Good Manufacturing Practices and documenting events following current Good Documentation Practices.
• Develop tools for tracking and trending reagent / RUO kit performance.
• Lead in interdepartmental activities with Lab Operations, Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are always available for use.
• Support management of supply chain, including supplier quality, inventory update. Ensure manufacturing raw material and consumables are adequately stocked.
• Serve as operations core team member for new product pipeline projects collaborating with R&D in developing, transferring, scaling, and validating manufacturing processes and quality control test methods for release as part of Design Transfer.
• Oversee daily operations of the reagent manufacturing department including but not limited to scheduling, troubleshooting, and resolving technical and non-technical issues.

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  Master’s degree (or higher) in biological science or health-related discipline.
• At least 3 years of industry experience in reagents/ kit manufacturing. Experience in Next- Generation- Sequencing (NGS) highly preferred
• Experience in ISO 13485 and/or GMP environment
• Demonstrated ability to develop positive working relationships with individuals and teams internally and externally with excellent problem-solving ability.
• Excellent written and verbal communication skills in English
• Strong organizational skills, attention to details, and able to multi-task.
• Project Management Certification preferred
• Previous experience with start-ups is a plus.

We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work. Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Predicine does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. We have in-house sourcing capacities. Please do not contact Hiring Managers.