Senior Manager, IVD Assay Manufacturing
Apply NowCompany: Pattern Bioscience
Location: Austin, TX 78745
Description:
Senior Manager, IVD Assay Manufacturing
About Pattern Bioscience
Pattern Bioscience is a fast-growing, clinical-stage startup tackling one of the biggest public health challenges of our time: antibiotic resistance. Using machine learning and microfluidics, we rapidly identify the bacteria causing infections and predict the most effective treatments.
The Role
We are seeking a strategic, collaborative, and entrepreneurial Senior Manager, IVD Assay Manufacturing to lead and scale a compliant consumable manufacturing operation for our high-resolution In Vitro Diagnostic (IVD) medical device. This role is critical in driving our production capabilities forward as we prepare for clinical trials and commercialization. If you're looking for an opportunity to make a significant impact in a startup environment while expanding your leadership skills and growing your career, we'd love to hear from you.
Key Responsibilities
Six-Month Goals
Requirements
Qualifications
Why Join Us?
We are building world-changing technology, and we need passionate individuals to help us succeed. At Pattern Bioscience, you'll work alongside a top-tier, multi-disciplinary team in a culture that values innovation, learning, and adaptability. We offer:
We celebrate diversity and are committed to fostering an inclusive environment. All qualified applicants will receive consideration for employment regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.
About Pattern Bioscience
Pattern Bioscience is a fast-growing, clinical-stage startup tackling one of the biggest public health challenges of our time: antibiotic resistance. Using machine learning and microfluidics, we rapidly identify the bacteria causing infections and predict the most effective treatments.
The Role
We are seeking a strategic, collaborative, and entrepreneurial Senior Manager, IVD Assay Manufacturing to lead and scale a compliant consumable manufacturing operation for our high-resolution In Vitro Diagnostic (IVD) medical device. This role is critical in driving our production capabilities forward as we prepare for clinical trials and commercialization. If you're looking for an opportunity to make a significant impact in a startup environment while expanding your leadership skills and growing your career, we'd love to hear from you.
Key Responsibilities
- Develop and execute production plans to meet product development and clinical trial needs.
- Monitor and report on process excellence metrics to ensure efficiency and quality.
- Define and implement effective design transfer requirements for new product introduction and changes.
- Drive continuous improvement initiatives in quality, compliance, safety, efficiency, and scalability.
- Optimize critical process parameters and ensure robust process control.
- Manage consumable-related BOMs, resource routings, lot size standards, and cost variances.
- Oversee maintenance of equipment and tools to ensure reliability and productivity.
- Lead validation activities for equipment, processes, and test methods.
- Build and develop a high-performing team aligned with organizational values.
- Address audit findings, non-conformances, and process improvement opportunities.
- Drive infrastructure enhancements and departmental budgeting processes.
- Promote a culture of safety, compliance, and operational excellence.
Six-Month Goals
- Implement NetSuite integrations with Arena PLM.
- Enhance electronic production execution systems.
- Establish critical business processes for clinical trial success.
- Deliver value stream mapping and targeted process improvements.
- Develop process validation plans, PFMEAs, and validation strategies for clinical trial readiness.
- Expand manufacturing capacity and establish requirements for future facilities.
- Recruit and onboard key hires to support clinical trial objectives.
- Define and implement process excellence KPIs and reporting standards.
Requirements
- Strong understanding of FDA regulations related to IVD medical device production (21 CFR 820, ISO 13485).
- Experience with cleanroom operations and formulation of high-complexity reagents.
- Expertise in Lean Manufacturing, Process Failure Mode and Effects Analysis (PFMEA).
- Proven ability to foster a safety-focused culture.
- Skilled in engineering change management and cost accounting principles.
- Analytical problem solver with a passion for continuous improvement.
- Clear and effective communicator, including strong technical writing skills.
- Experienced people manager who values team development and cross-functional collaboration.
Qualifications
- B.S. in a technical or life sciences-related field.
- Minimum 7 years of experience in biotech or medical device manufacturing.
- At least 5 years in a leadership or management role.
- Experience with lyophilization and/or BSL-2 environments is a plus.
Why Join Us?
We are building world-changing technology, and we need passionate individuals to help us succeed. At Pattern Bioscience, you'll work alongside a top-tier, multi-disciplinary team in a culture that values innovation, learning, and adaptability. We offer:
- Health insurance.
- 401(k) matching.
- Paid time off.
- The opportunity to make a global impact.
We celebrate diversity and are committed to fostering an inclusive environment. All qualified applicants will receive consideration for employment regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.