Production Manager - San Jose, CA | Biospace
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Production Manager


San Jose, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Product Manager,

Job Description

Plan, direct, and manage the activities of the Production Department including developing and implementing strategies/processes/procedures to ensure the timely liquid/powder filling, labeling, kitting functions of existing BTSM products to meet regulatory and customer requirements.  Development and implementation of BTSM new (POC to Point-of-Care) lateral flow product line to regulatory and customer requirements.

Duties and Responsibilities:

Develop and lead POC Lateral-Flow and liquid /powder filling, labeling, and kitting activities in the Production department
Direct the development and installation of procedures, controls and reports in order to maintain the communication and management control/direction within the department.
Support the commercialization/design transfer of new IVD products from R&D, external partners/customers
Department staff development to existing and new processes, procedures, policies in compliance with GMP, FDA, Quality Management System, and other Quality and Regulatory requirements.
Ensure availability of supplies, tools and fixtures for product assembly.
Ensure adequate work-flow; production targets are met.
Establish and maintain a safe, secure, controlled and efficient operating environment.
Evaluate operating results on a regular and systematic basis.
Implement policy and procedural changes where applicable to overcome operating deficiencies and continuously improve results.
Interact heavily with Operations, Manufacturing, Quality Assurance, and other departments/partners to create/implement programs for quality monitoring and improvement, volume demand increases and cost reduction improvements.
Coordinate equipment vendors and suppliers with Operations Management.
Coordinate raw material supplying, finished good schedule of receipts and production problem resolution with Operations Management.
Manage department functional training.
Complete annual performance evaluations and development plans for direct reports.
Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP), and all related SOPs.
Ensure and maintain compliance with the Company’s quality management system requirements through training, adherence to policies, procedures, and processes.
Other duties as assigned.



Leader: Inspires teammates to follow them
Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization

Bachelors or better in Business Administration or related field.

10 years: 10+ years Manufacturing/production management; experience with manufacturing/production environment testing and troubleshooting within an FDA-regulated environment; lateral flow manufacturing and production experience.