The Supply Chain Manager will be responsible for overseeing and optimizing the end-to-end supply chain operations at Nuclein. The individual will collaborate closely with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs to ensure the seamless production, distribution, and availability of our product(s) while complying with strict FDA regulations.

Essential Duties and Responsibilities. 

        ·         Develop and execute supply chain strategies aligned with company objectives.    

        ·         Identify, evaluate, and manage relationships with suppliers and vendors. Oversee all Procurement and Planning activities

        ·         Collaborate with sales, marketing, and finance teams to create accurate demand forecasts.

        ·         Establish and maintain optimal inventory levels while minimizing excess and obsolete inventory. Oversee all Material Handling and material receipt and storage activities.

        ·         Ensure all supply chain activities adhere to FDA regulations and compliance requirements.

        ·         Coordinate with manufacturing to develop production schedules that meet demand forecasts.

        ·         Manage transportation, distribution, and warehousing activities.

        ·         Proactively identify potential supply chain risks and develop mitigation strategies.

        ·         Establish and track key performance indicators (KPIs) to measure supply chain performance. 

        ·         Collaborate with internal teams to align supply chain strategies with business goals.

        ·         Develop a high performing supply chain team including Procurement, Planning, Material Handling and Distribution

Education, Qualifications, and/or Experience. 

·         Bachelor's degree in supply chain management, operations, business, or related field. Master's degree or relevant certification (e.g., APICS, CSCP) is a plus.

·         At least 5 years of progressive supply chain leadership experience, preferably in the medical device or diagnostics industry. IVD/PCR experience strongly preferred.

·         Familiarity with FDA regulations and quality management systems (e.g., ISO 13485); ability to operate in an FDA-regulated environment.

·         Strong leadership skills with the ability to lead cross-functional teams and manage projects effectively.

·         Proficiency in data analysis, demand forecasting, and inventory optimization.

·         Excellent written and verbal communication skills.

·         Demonstrated problem-solving and analytical skills.

·         Proficiency in supply chain management software, ERP systems, and Microsoft Office Suite.

·         Ability to thrive in a dynamic and fast-paced environment, managing multiple priorities simultaneously. 

·         Ability and willingness to travel up to 10%

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Position: Mostly sitting

·         Speaking and communicating

·        Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

THIS ROLE IS 100% ON SITE IN AUSTIN, TX | LOCAL CANDIDATES ONLY | NO RECRUITERS OR AGENCIES, PLEASE | SPONSORSHIP IS NOT OFFERED AT THIS TIME

The Manufacturing Supervisor will provide front-line support for Nuclein’s manufacturing operations. The individual will be responsible for overseeing day-to-day manufacturing activities, ensuring compliance with FDA regulations and GMP guidelines, and contributing to continuous improvement initiatives to optimize efficiency and product quality.

Essential Duties and Responsibilities:      

• Front-line support for Nuclein’s manufacturing operations, ensuring adequate resources, manufacturing capacity and planning as well as assisting in coordinating the direct labor and test technician operations
• Follow and support required cGMP production processes and procedures.
• Monitor production metrics and support corrective actions as needed.
• Ensure strict adherence to FDA regulations and GMP guidelines through audits and daily oversight.
• Help coordinate and develop training documentation and plans for assembly team members.
• Collaborate with the Quality Assurance and Quality Control teams to address quality issues.
• Help identify opportunities for process optimization and efficiency improvements.
• Implement lean manufacturing principles to streamline operations.
• Participate in and support continuous improvement projects.
• Supervise and support a team of assembly personnel, and participate in the interviewing/hiring process as needed
• Foster a culture of teamwork, accountability, and continuous improvement.
• Participate in performance evaluations and provide coaching to team members.
• Promote a safe working environment by enforcing safety protocols.
• Investigate and report safety incidents, implementing preventive measures.
• Monitor department costs and escalate concerns as appropriate

Education, Qualifications, and/or Experience: 

• Associate’s degree required with bachelor’s degree preferred
• At least 5 years of experience in manufacturing operations or equivalent role(s) required, preferably in the medical device industry
• Experience operating in environments of FDA regulations and GMP guidelines required
• Excellent problem-solving and decision-making skills.
• Ability to support process improvements and contribute to cost reduction efforts.
• Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment.
• Ability to operate with general supervision and escalate issues appropriately.
• Ability to work cross-functionally to ensure all manufacturing objectives are met.
• Possesses a high level of attention to detail and organization.
• Ability to prioritize tasks and to delegate them when appropriate.
• Experience in using/navigating ERP systems
• Proficient with Microsoft Office Suite or related software to complete reports and logs.

Physical Requirements:  

• Repetitive Motion: Mostly computer use
• Weight Lifting: at least 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

LOCAL CANDIDATES ONLY- SPONSORSHIP IS NOT OFFERED AT THIS TIME

The Quality Control Supervisor will be responsible for training personnel and planning, facilitating, and executing QC activities to inspect and test Nuclein’s diagnostic medical devices, subassemblies, and components.  The role involves maintaining a high level of quality in the product by ensuring adherence to specifications, applying rigor, technical knowledge and skills to daily operations, and collaborating with team members on investigations. The QC Supervisor has working knowledge of the qc methods, criteria and strategy and the ability to train and develop QC Technicians.

Essential Duties and Responsibilities. 

        ·         Supervises, trains, and mentors QC personnel

        ·         Coordinates and deploys QC resources in an efficient manner to meet production schedules

        ·         Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance

        ·         Maintains work area and equipment to GMP standards, performs equipment maintenance and metrology, ordering/receiving supplies

        ·         Performs data analysis, records results, approve results, and archives quality records

        ·         Understands the Quality Control strategy

        ·         Recognizes and reports deviations, non-conformances, and out of specification events promptly and accurately, performs material quarantine

        ·         Initiates Nonconformance (NC) with appropriate information, assists with investigations and resolves NCs as assigned

        ·         Reviews quality records for completeness, accuracy, and compliance, resolves discrepancies

        ·         Leads work instructions creation/revision, supports test method development and continuous improvement efforts as assigned

        ·         May participate in validation activities

        ·         May support quality audits

Education, Qualifications, and/or Experience. 

       ·         Associate’s degree or higher in a technical discipline or equivalent work experience

       ·         Minimum 4 years QC work experience required, 2+ years in medical device or other regulated industry required

       ·         Previous supervisory experience preferred

       ·         Quality certification, such as ASQ CQI, CQT or ASME GD&T preferred

       ·         Strong computer skills and experience with laboratory equipment

       ·         Strong attention to detail and problem solving skills

       ·         Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance

       ·         Proficiency reviewing records for completeness and accuracy

      ·         Strong organizational and time management skills

Physical Requirements.  

       ·         Repetitive Motion: Picking and placing parts, use of laboratory equipment, computer use

       ·         Weight Lifting: < 50 lbs

       ·         Position: Sitting and standing

       ·         Speaking and communicating

       ·         Use of PPE may be required in laboratory/manufacturing/warehouse areas

      LOCAL CANDIDATES ONLY - SPONSORSHIP IS NOT OFFERED AT THIS TIME

The Regional Sales Manager role at Nuclein is responsible for driving direct and distributor sales within their assigned region, ensuring the achievement of cartridge/consumable revenue objectives and system placement targets for the DASH® Rapid PCR platform.  Reporting directly to the Vice President of Sales, the Regional Sales Manager will execute region-specific sales strategies, build and maintain strong relationships with customers, distributor partners, and key accounts operating within their assigned region, as well as contribute to the overall growth and success of their assigned sales area.  This role requires developing, managing, and maintaining accurate and up-to-date sales forecasts to meet or exceed assigned regional objectives.

Essential Duties and Responsibilities 

Territory Sales and Strategy Execution:

·       Drive sales of DASH® cartridges, consumables, and system placements within the assigned region.

·       Ownership of the entire sales process including prospecting, qualification, positioning/value creation, product demonstration, pricing proposal, negotiation/contracting, implementation, and account management.

·       Develop and execute sales strategies that align with regional, area, and company-wide objectives.

·       Collaborate with the Vice President of Sales to create and implement tactical plans for regional growth and expansion.

·       Continuously monitor and analyze market conditions, customer needs, and competitor activity to adjust strategies as necessary.

Distributor and Customer Relationship Management:

·       Build and maintain strong relationships with distributor partners to drive sales growth.

·       Serve as the primary point of contact for customers in the region and ensuring customer satisfaction.

·       Engage in regular communication with distributor contacts to monitor performance and identify opportunities for growth.

Revenue and System Placement Goals:

·       Achieve monthly, quarterly, and annual targets for DASH® cartridges, consumables, and system placements.

·       Accurately maintain sales forecasts, pipeline data, and CRM records to track performance and provide actionable insights to the Vice President of Sales, the commercial organization, and the company.

Sales Strategy and Execution:

·       Develop and execute region-specific business plans that incorporate market strategies, competitive analysis, customer insights, distributor updates, and individual performance.

·       Work with internal teams, including marketing, to align efforts and ensure cohesive execution of sales strategies.

·       Leverage CRM tools to manage customer base, track activities, monitor performance, and provide accurate forecasts.

·       Lead regional planning efforts to identify high-potential customers and specific opportunities to drive growth.

Collaboration and Cross-Functional Engagement:

·       Work closely with internal teams, including marketing, operations, and customer support, to ensure successful product launches, promotional campaigns, and ongoing customer support.

·       Participate in field visits with the Vice President of Sales to identify opportunities for improvement and ensure alignment with company objectives.

·       Provide regular updates on regional activities, including customer feedback, market trends, and competitor insights.

Business Acumen and Financial Management:

·       Ensure fiscal responsibility by controlling expenses and ensuring the company’s profitability targets are met.

·       Satisfy administrative requirements on time (e.g. Expense Reporting, Monthly Reports, Business Plans, Projects)

·       Speaking and Communicating