At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. Our technology rapidly identifies bacterial infections and predicts the most effective antibiotics to treat the infection. We’re building direct-from-specimen phenotypic rapid ID/AST assays using live cells on our proprietary instrument and consumable platform.
We are seeking an adaptable, entrepreneurial-minded, collaborative and strategic Sr. Manager of Consumable Manufacturing to evolve and scale a compliant consumable manufacturing operation for our high resolution In Vitro Diagnostic (IVD) medical device. You will be responsible for the direction, planning, and performance of consumable manufacturing operations and play a key part in moving our production capabilities into the next stages for clinical trials and commercialization. This is a great opportunity to demonstrate and expand your leadership capabilities in a startup environment.
Below, you’ll find lists of opportunities to make an immediate impact, key areas of responsibility, core competencies we’re seeking and specific skills. If you see yourself in the majority of what’s listed but not all, we still encourage you to apply.
Six Month Goals
- Optimize NetSuite and implement targeted functionality
- Identify and implement critical business processes needed for clinical trial compliance
- Provide Value Stream Mapping
- Deliver targeted process improvements and specification hardening
- Facilitate design transfer of product changes in scope for clinical trial start
- Produce process validation master plans, PFMEAS, and validation of equipment, methods, and processes needed for clinical trial readiness
- Expand the team to support clinical trial production volumes
- Determine KPI’s and standardize reporting
- Formalize requirements for new consumable manufacturing facility and work with designers to finalize design outputs
How You Will Contribute
- Establish, refine, and execute production plans, including identifying and securing resource requirements to meet organizational needs
- Develop, monitor, and report on effective department performance metrics
- Generate effective design transfer requirements for new product introduction and product changes
- Identify and implement continuous improvement initiatives targeting quality, compliance, safety, efficiency, scaling, and cost; and business process optimization and lean initiatives to eliminate waste and enhance operational control, responsiveness, and flexibility
- Facilitate optimization and guard-banding of critical process parameters
- Manage consumable related BOM’s, resource routings, lot size standards, and variances to maintain accurate costing
- Ensure total productive maintenance of equipment and tools
- Confirm effective equipment, process, and test method validations
- Develop team capabilities in alignment with organizational needs and values
- Assure effective prioritization, investigation, and resolution of findings impacting Consumable Manufacturing identified through audits, non-conformances, corrective/preventative actions, and customer complaint escalations
- Guide the design and implementation of infrastructure improvement initiatives
- Drive departmental capital, headcount, and expense budgeting requirements and maintain accountability to budget integrity and financial performance
- Promote a culture of safety adherence to safety, hazardous waste disposal, and gowning requirements
We’d Love to Hear from You if You
- Have a strong track record of enabling a safety culture
- Apply Engineering Change management best practices appropriately
- Utilize a working knowledge of cost accounting
- Enjoy problem-solving, strategic planning, root cause analysis, and applying data analysis to improving your organization
- Communicate efficiently while still delivering clarity and supporting collaboration – including technical writing
- Value effective people management and developing team members
- Build strong relationships inter- and cross-departmentally
Desired Education & Experience
- A strong understanding of FDA regulations related to IVD medical device development and production – particularly 21 CFR 820, ISO 13485, cleanroom operations and clean formulation of reagents, Lean Manufacturing principles, and Process Failure Mode and Effects Analysis (PFMEA)
- B.S. in a technical or life sciences-related field
- Min 7 years of experience in a biotech or medical device manufacturing environment
- Min 5 years of experience in a management or leadership role
- Lyophilization and/or BSL-2 safety understanding a plus
We highly value team members who can demonstrate clear (and where possible, quantifiable) achievements and encourage you to highlight those in your application.
Join us! We’re excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our
website.
Benefits
* Health insurance
* 401k Matching
* Paid Time Off
* The opportunity to make a global impact
To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, neurodiversity, status as a qualified individual with disability, protected veteran status, hair texture or protective hairstyle, or any other characteristic protected by law.
