Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.

The Scientist III Panels, Manufacturing that supports our Agena Biosciences business has responsibility for sets up, transfers, manufactures, and continuously improves the molecular diagnostic formulations associated with diagnostic assay panels and related reagent consumable components. The Scientist III will plan, organize, and execute assay builds in the Manufacturing department in a fast-paced, multidisciplinary team.

Key Job Responsibilities:

• Drafts technical instructions and procedures to formulate, fill and package molecular biology consumable assay components; transfers new processes and new products to manufacturing setting.
• Develops and implements design control, QSR and master validation plans/deliverables for FDA regulated materials.
• Completes panel builds (formulation and fill)
• Champions and rigorously follows Good Laboratory Practices (GLP)
• Implements supply chain and inspection techniques, process automation, environmental requirements, and testing methods
• Supports facility, process and instrumentation IQ/QQ/PQ, and the development of regulatory submissions
• Investigates non-conformances and field complaints
• Closely interacts with R&D, Manufacturing, Materials, Regulatory and QA/QC departments in new product introduction and technical troubleshooting projects
• Monitors compliance to procedures and standard cost evaluations/variances
• Complies with all documentation and production record keeping
• Initiates TQM and metric development, corrective, and preventative action projects
• Assists in the GMP formulation of complex mixes
• Develops and provides direction to 1-2 direct reports
• Manages the production schedule for panel/assay builds and rebuilds
• Suggests and may lead outsourcing efforts for equipment design and manufacturing process improvements

Qualifications/Education:

• Bachelor's degree in biochemistry, chemistry or related sciences with 7+ years of relevant experience in a GMP/GLP manufacturing environment.
• Must have diagnostic experience
• ERP environment experience for manufacturing and shop floor controls, BOMs, routings
• Experience with nucleic acid detection methods and assay development using PCR methodologies that include primer design, real-time PCR, MassARRAY, capillary electrophoresis, or next-generation sequencing is desired.

Compensation/Benefits:

The company offers a comprehensive benefits package and compensation for this position. The package includes base salary, bonus, medical/dental/vision insurance, 401k/Match.

Salary Range for this position is $112,000-$134,000.

Mesa Labs is an Equal Employment Opportunity Employer.

Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law.