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Manager, Reagent Manufacturing

Location: Newark
Posted on: January 27, 2023

Job Description:

Job Details


Job Location
Newark, CA - Newark, CA

Position Type
Full Time

Education Level
Bachelor's Degree

Travel Percentage

Job Shift

Job Category


By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Salary Range: 112K-168K depending on experience

Position Summary:

As the manager of the Manufacturing team, the individual plays a critical role in manufacturing operations with the following responsibilities. Strategically manages tasks and projects relating to Production and Operations with significant autonomy. Ensures reagent products are produced in sufficient and consistent quality to meet market demand. Ensures production schedules and support activities are aligned to meet demand and effective planning and allocation of resources. Coordinates with Planning, Materials Management, and other support teams to ensure that product lead times are achieved. Makes recommendations on improvements in production cost, quality, and efficiency. Ensures production processes are adequately developed, documented, and performed in compliance with company procedures and external regulatory requirements. Troubleshoots problems that impact manufacturing workflow or production schedules. Collaboration within and between departments to achieve high performance working teams on projects. Responsible for managing performance of production supervisors and manufacturing staff. This position reports to Director of Manufacturing. This position is based in Newark, CA

Key Responsibilities:

  • Collaborate with Operations to establish a production schedule, plan, and resource allocation based on forecast.
  • Oversee reagent production output to ensure market demand, sales forecasts, and internal R&D needs are met.
  • Work with QA/RA Department to establish, implement, and maintain compliant production process and controls.
  • Continuously monitor, maintain, and improve the efficiency of production processes.
  • Monitor and assess the operational conditions of facility and equipment used in production to ensure uninterrupted production and requirements.
  • Review validation protocols and reports in support of validations, equipment commissioning, qualification, and change management.
  • Oversee the transfer activities of new RUO products into production.
  • Coordinate and collaborate with Development and oversee the product transfer activities for IVD/CE products.
  • Apply process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into manufacturing.
  • Handle deviations and CAPA investigations.
  • Draft and revise manufacturing documents.
  • Hire, train, coach, manage, and evaluate performance of employees.
  • Monitor team's safe work habits and ensure adherence to all safety procedures and guidelines.


    Education and Experience:
    • BS or MS in biology, biochemistry, chemical engineering or similar disciplines or equivalent work experiences.
    • Minimum of 8 years of relevant industry experience preferably in a regulated environment in reagent manufacturing or equivalent combination of education and experience.
    • Experience in ISO 13485 and/or 21CFR Part 820 preferred
      Knowledge, Skills and Abilities:
      • Solid and effective communication skills with strong attention to details.
      • Demonstrate strategic problem-solving skills.
      • Proven leadership skills with ability to build trust and grow teams.
      • Technical proficiency that enables effective oversight of the production process.
      • Knowledge of and experience with chemical, instrument or facility production processes, and process equipment.
      • Experience with automation filling a plus.
      • Experience in product and process validations.
      • Experience with ERP or other manufacturing inventory management systems.
        Why Join Bio-Techne:
        • We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
        • We invest in our employees' financial futures through 401k matching and an employee stock purchase plan.
        • We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
        • We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
        • We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
          Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.

          Bio-Techne is an E-Verify Employer in the United States.

Keywords: BIO-TECHNE, Newark , Manager, Reagent Manufacturing, Executive , Newark, California

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