Manager, Production - San Marcos, CA- DRD/Bio-Techne

By joining Bio-Techne, San Marcos you’ll join a proven leader in the Manufacturing of In-Vitro Diagnostics. Our Research Associates are focused on the product development of diagnostic assays, to include reagents, calibrators, controls, calibration verifiers and proficiency testing. When you join us, you will be part of a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all its brands, provides tools for researchers to further treat and prevent disease worldwide.

Full compensation for this range is $99,000-$143,000 10% Management Incentive Plan Long Term Incentive/equity.

Position Summary:

Plan, direct, and manage the activities of the Production Department including the Production schedule, developing, and implementing strategies/processes/procedures to ensure the timely liquid/powder filing, labeling, kitting functions of existing BTSM products for our San Marcos based operations.

Key Responsibilities:

• 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 adequate workflow; 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.
• Work cross-functionally with Project Management, QA/QC, Finance, and Operations to meet business objectives and implement process 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.

Knowledge, Skills and Abilities:

• Thorough knowledge of GMP-FDA regulations, ISO 13485, cGMP, GLP, & SOX.
• Strong planning, organizational and time management.
• Competency in materials requirement, capacity planning, financial and variance analysis, new product and process costing, and budgeting required.
• Knowledge of leadership, managerial and supervisory techniques.
• Promote teamwork in own department and across other departments.
• Must have sufficient English communication skills to understand verbal and written instructions.
• Ability to analyze trends and statistical data and make appropriate decisions and recommendations. Clearly communicate to Sr. Management.
• Ability to prioritize multiple tasks and work well as part of a team.
• Must have sound, basic knowledge of computers and software programs that support production planning and process. (Smartsheet Experience Preferred.)
• Knowledge of the metric measurement. Good mathematical ability.
• An exceptional orientation to detail and accuracy.
• Knowledge of ERP/MRP systems.

Minimum Job Requirements:

Post-secondary education preferred; >8 years’ experience manufacturing /production management experience. Experience in Biotech medical / diagnostic production setting strongly preferred.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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