POSITION SUMMARY:

This position is primarily responsible for the operational management of in-Vitro Diagnostics Manufacturing and related support functions, including production planning, shipping and receiving, and developing and implementing manufacturing policies and processes. Maintain and develop a team-oriented workforce to achieve and / or exceed business and partner objectives. Promote continuous improvement within areas of reliability, time efficiency, and personnel management. Develop and implement production plans in a manner that aligns with identified objectives. Cultivate a dedicated team within a fast-paced and growing environment.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Work closely with senior management to develop policies, procedures, and systems and to follow through with implementation and enforcement.
• Contribute to the development of processes for receiving the product, equipment utilization, inventory management, and shipping. Implement changes as necessary.
• Work with staff, team leaders and senior management to identify process improvement opportunities within the department.
• Work cross-functionally to implement production scale-ups.
• Maintain and revise SOP's and GMP documentation
• Maintain a relationship with key operations vendors
• Use ERP system to fullest capabilities to improve efficiency, reduce errors, etc.
• Contribute to strategic plans and reviews; prepare and complete action plans; implement production, productivity and quality standards; resolve problems; prepare and participate in audits.
• Work with quality and regulatory departments to ensure processes are in compliance with all FDA, ISO/13485 and other external/internal quality requirements.
• Work with the Regulatory team to ensure all regulatory documents are completed and filed in compliance with regulations.
• Maintain a safe and healthy work environment by establishing, following and enforcing standards and procedures; complying with regulations.
• Support employee communication with senior management.
• Communicate policies and information to the department from senior management.
• Review production, inventory, equipment capacity, and utilization regularly.
• Staff operational areas at appropriate levels with fully qualified individuals capable of performing duties to the required level of proficiency
• Work across departments to achieve company and departmental objectives and build teamwork.
• Provide leadership and direction to the operations and production staff. Establish performance requirements and monitor achievements. Ensure ongoing staff development of a growing department.
• Develop and maintain a thorough understanding of ArcherDX clients and the IVD assay market.
• Acquire a strong knowledge of the production processes and all associated equipment.
• Manage to troubleshoot of manufacturing related issues and identify resources and action plans to resolve these issues.
• Create and nurture a continuous improvement program and culture focusing on lean manufacturing processes.
• Help promote a company culture that encourages top performance and high morale.
• Maintain ArcherDX values and mission within the department, and plan for short and long-term goals.

EXPERIENCE:

• 7-10 years’ experience in operations, manufacturing, or similar environment.
• Previous management experience.
• Experience at an FDA regulated biotech, pharmaceutical, or medical device manufacturer
• Previous experience with manufacturing of class 2 and preferably class 3 Medical Device
• History of successful performance in a fast-paced environment with a proven ability to make important decisions, often under pressure and tight deadlines.
• Experience managing complex cross-function projects/programs.
• Understanding of best practices within human resources and team development.
• Understanding of general finance and budgeting.

KEY ATTRIBUTES:

• Functional knowledge of key business processes in a medical device manufacturing environment.
• Expert proficiency at managing day-to-day operational aspects of a project and scope.
• Demonstrates the ability to manage projects and teams, multi-task and achieved desired results, especially under pressure.
• Demonstrates strong verbal, listening and written communication skills, organizational and time management skills, presentation skills and attention to detail.
• Ability to translate broad strategies into specific objectives and action plans.
• Ability to foster and maintain relationships with individuals representing a wide diversity of disciplines and levels of sophistication in a collaborative environment.
• Ability to influence, develop, motivate and empower employees to achieve objectives with a team approach.
• Demonstrates strategic and critical thinking with strong analytical and problem-solving skills.
• Ability to build consensus and relationships among managers, partners, and employees.
• Deadline and deliverable driven individual with an ability to adapt to/in unexpected or abnormal results or situations.
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Self-starter driven to perform with the ability to organize, prioritize, and delegate tasks to efficiently move projects forward.

EDUCATION:

Bachelor’s degree in a related field. Advanced degree a plus.