POSITION TITLE: Senior Manager of Manufacturing
DEPARTMENT: Operations
REPORTS TO: VP of Operations
JOB STATUS: Exempt
Imagine ordinary healthcare workers or first responders conducting sensitive nucleic acid tests in a near-patient setting or in the field by simply collecting a sample into a test tube, inserting the tube into a handheld analyzer, and getting the test results within 30 minutes, without further human intervention. IQuum’s Liat™ Analyzer makes this vision a firm reality.
I. JOB SUMMARY: Key Manufacturing leader in exciting and high growth environment. Responsible for all aspects of manufacture of IQuum’s Liat™ Analyzer platform; a rapid, near patient nucleic acid testing system.
Develop and quickly implement comprehensive operating and organizational plans to meet significant anticipated market demand and scale up manufacturing operations while maintaining high productivity, high quality and low cost.
Build operational systems, metrics, process and control capabilities related to material, labor and overhead consumption providing accountability for material and labor utilization, productivity, cost and quality.
Responsible for material control function aligned with Quality Function and related procedures for receiving, inspecting and stocking materials. Establish inventory control procedures.
Develops, implements and maintains detailed build plans, production schedules and manpower requirements. Responsible for manufacturing employee hiring, training and performance and ensuring a consistent adherence to world class operational practices.
Ensures functional unit’s compliance with GMP, ISO13485, FDA and all related elements such as facilities, documentation (SOPs and validations protocols, etc.) training, reports and records. Supports ongoing FDA clinical studies.
Build and manage Service function for Liat Analyzer; develop organization, processes, systems and key metrics to ensure timely world class service for customers and timely remediation of customer service/repair requests.
Lead direct reports to build the right group and a winning culture; hold reports accountable with high standards and provide timely feedback on performance and provide coaching for career development.
Comply with all quality system and safety requirements, generate and maintain SOP’s and make comprehensive and timely documentation of operational plans and completed activities.
Interact extensively with procurement, engineering, biology and senior management to ensure alignment on strategic, operational and financial goals.
EDUCATIONAL REQUIREMENTS: BS Degree in Mechanical Engineering preferred or BS Degree in manufacturing/operational discipline.
OTHER REQUIREMENTS:
10+ years direct manufacturing experience with demonstrated track record of success; at least 5 years manager-level experience responsible for leading instrument manufacturing teams.
Experience in a medical device environment and ability to lead teams in a technically complex and fast-paced environment
Capability to be process oriented and analytical and also focus on detailed aspects of manufacturing processes when required
Extensive technical knowledge in electro-mechanical instrumentation, including PCBA, surface mount technologies, optics and other aspects of complex instrument manufacturing
Working knowledge and direct experience with GMP, ISO13485 and other process and documentation requirements for the FDA and other regulatory bodies
Ability to establish, measure and manage key operational metrics related to production including yields, materials utilization, inventory management, build planning and other operational areas
Highly proactive and energetic leader with ability to quickly identify and solve operational challenges in a high growth environment
Ability to effectively communicate on a timely basis with all functional areas of the Company
Hands-on approach and ability to multi-task; positive attitude and one who leads by example to foster a winning culture and team
Strong work ethic and willingness to put forth extra efforts when required to meet Corporate goals
CONTACT: Send resume and salary history and requirements to Daniel J. Sutherby, CPA, Chief Financial Officer; [email protected] 508-970-0099, x 120
IQuum has developed a novel biological sample testing technology that is intended to provide revolutionary benefits to a broad cross section of the bioassay market. Our proprietary lab-in-a-tube technology will enable the less experienced personnel to perform more sophisticated biological sample testing in a less expensive setting with greater speed. We believe that our lab-in-a-tube platform is the foundation of next generation tools for clinical diagnostics, therapeutic monitoring, biodefense, and agricultural and industrial biological sample testing. www.iquum.com
About the Liat™ Analyzer The Liat system refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat Tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. The Liat Analyzer’s small size (~4.3” x 8” footprint), fully integrated and self-contained design, along with its closed tube design and robust error prevention features, will make it ideally suited for future tests near-patient or on-site molecular diagnostics. IQuum’s ultimate goal with the Liat system is to enable nucleic acid tests to be conducted rapidly and reliably by non-specialized personnel at the near patient or other decentralized settings.
IQuum, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.
