Senior Manager, Consumables Manufacturing

Pattern Bioscience•Austin, TX

About The Position

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize bacteria causing infections and predict effective drug treatments. We are seeking a collaborative, strategic leader to evolve and scale a compliant manufacturing operation for our high-resolution In Vitro Diagnostic (IVD) medical devices.

Requirements

Have a deep understanding of FDA (21 CFR 820) and ISO 13485 regulations.
Are proficient in cleanroom operations, reagent formulation, analytical methods, and Lean Manufacturing.
Are a collaborative problem-solver who enjoys root cause analysis and applying data to improve an organization.
Have a strong track record of promoting a safety culture and effective people management.
Communicate with clarity, supporting both technical accuracy and team collaboration.
Education: B.S. in a technical or life sciences-related field.
Experience: 7+ years in biotech/medical device manufacturing, including reagent and/or consumable manufacturing
5+ years in a leadership role.

Nice To Haves

Experience with Lyophilization and BSL-2 environments.

Responsibilities

Operational Leadership: Develop and execute production plans, manage resource requirements, and report on performance metrics.
Building & Scaling: Drive continuous improvement and Lean initiatives to optimize quality, safety, and efficiency. Lead the identification and implementation of new process capabilities.
Analytical Methods: Operationalize analytical methods including HPLC
Financial Accountability: Manage departmental budgeting (CAPEX, headcount, OpEx) and maintain accurate costing. Authorize section expenditures and maintain accountability for budget integrity.
Cross-Functional Collaboration: Partner with stakeholders and key business partners to support the operation, develop business system roadmaps, and ensure effective design transfers.
Quality & Compliance: Ensure QMS compliance, lead investigations (CAPA, non-conformances), and oversee equipment/process validations (IQ/OQ/PQ).
Safety & Maintenance: Ensure total productive maintenance of tools and operational adherence to safety and hazardous waste disposal requirements.