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Manufacturing Manager

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Predicine, Inc.

2021-12-03 07:32:33

Job location Hayward, California, United States

Job type: fulltime

Job industry: Manufacturing Operations

Job description

Manufacturing Manager is responsible for sufficient inventory of qualified reagents in the laboratories of clinical and research operations.

* Lead in interdepartmental activities with Lab Operations, Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are always available for use.
* Provide technical leadership and support for reagents manufacturing and management for NGS lab and Covid lab
* Lead in the development and revision of reagent manufacturing documentation like SOPs, batch records and material specifications.
* Oversee daily operations of the reagent manufacturing department including but not limited to scheduling, troubleshooting, and resolving technical and non-technical issues
* 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.
* 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.
* Support supplier management of critical suppliers including testing services, reagent suppliers, and manufacturers.
* Support management of supply chain, including supplier quality, inventory update. Ensure manufacturing raw material and consumables are adequately stocked.

* Work with finance to ensure cost accounting is accurate, and identify variances and cost reduction opportunities related to reagent/ kit manufacturing

* Participate in internal and external audits.

Requirements

* Bachelors 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.

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