Manager, Reagent Manufacturing
Posted on: January 27, 2023
Newark, CA - Newark, CA
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
Salary Range: 112K-168K depending on experience
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
- 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
- Monitor and assess the operational conditions of facility and
equipment used in production to ensure uninterrupted production and
- Review validation protocols and reports in support of
validations, equipment commissioning, qualification, and change
- Oversee the transfer activities of new RUO products into
- 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
- 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
- Demonstrate strategic problem-solving skills.
- Proven leadership skills with ability to build trust and grow
- Technical proficiency that enables effective oversight of the
- 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
Why Join Bio-Techne:
- We offer competitive salaries along with extensive medical,
vision, and dental plans for you and your family starting on day
- 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
- We foster a culture of empowerment and innovation, where
employees feel valued and encouraged to bring their new ideas to
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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