COMPANY SUMMARY:

POSITION SUMMARY:
Operations Management professional who will lead the development and management of the company’s IVD/CDx and RUO manufacturing capabilities, to include operations and engineering departments. This role will be hands-on and will provide overall manufacturing leadership for Colorado Operations to develop, execute and manage new product manufacturing via process development and validation and test method validation. This position will ensure the company provides its internal and external customers with industry leading and innovative products and services that meet or exceeds established requirements including US FDA regulations, GMP (good manufacturing practice) and ISO 13485:2016.
RESPONSIBILITIES:

• Develop and oversee cGMP-level production related activities, procedures and records for IVD and companion diagnostic manufacturing and logistics;
• In coordination with Strategic Operations, implement and execute manufacturing operations to meet and/or exceed the strategic goals of the company’s global regulated product manufacturing, engineering, and associated process lines;
• Provide guidance and leadership in the diagnosis and resolution of production problems; 
• Develop and/or test the feasibility of new manufacturing technologies and their introduction into a cGMP environment;
  Manage external subcontractors:
• Lead by example to create an inclusive culture that values high engagement;
• Collaborate with the Diagnostic Strategy Program Management Office to ensure effective resource utilization, planning, and execution of projects that are in alignment with company objectives;
• Recruit, direct, coach and develop talent in the Colorado Operations organization to maintain a high level of technical expertise that works collaboratively with key partners;
• Review personnel performance and compensation;
• Responsible for all hiring decisions within the team, including obtaining new position approvals;
• Develop annual budget and achieve financial results;
• Develop, monitor and report on KPI’s related to operations;
• Assist and provide critical feedback on production process development;
• Partner cross-functionally on needed logistics capabilities;
• Advise on scalability and product/services expansion;
• Build and maintain positive and collaborative relationships cross-functionally with management, peers, subordinates, and externally with third party suppliers, contract organizations, and regulatory authorities to advance strategic priorities; 
• Maintain safe and clean facility and site;
• Prepare for and participate in audits;
• Review, understand, and comply with ArcherDX HIPAA Security policies and procedures;

EXPERIENCE:

• 10+ years experience leading transformative change in a development or manufacturing environment;
• Demonstrated success in manufacture of IVDs would be highly desirable;
• Experience developing a scalable efficient compliant organization;
• History of integrating processes in medical device manufacturing and maintenance;
• Working knowledge of cGMP/CFR/FDA regulations and ISO standards.

KEY ATTRIBUTES:

• Must be hands-on, self-directed, organized and conscientious;
• Demonstrated hands on change management leadership skills;
• Excellent written and verbal communication skills;
• Problem solving prowess in consistently evolving environment;
• Proven ability to work under pressure and with short deadlines to accomplish objectives;
• Ability to communicate effectively with technical and non-technical personnel.

EDUCATION: 

• Bachelor’s degree required;
• Graduate degree in molecular biology, engineering and/or relevant scientific discipline highly desired;
• Knowledge of manufacturing in a regulated environment (ISO 13485, 21CFR820, cGMP) and related manufacturing and process control requirements.