Leads all aspects of Instrument Manufacturing for Advance Staining, Primary Staining and Sequencing Solutions platforms portfolio and service parts. Deliverables include: instrument cost, quality, safety and production plan targets, P&L achievement, continual FDA compliance, new product launches and continuous improvement of overall manufacturing competitiveness. Partners with, and shares full performance metric accountability with, Global Supply Management, Reagent Manufacturing and, Quality & Regulatory.. Maintains Instrument manufacturing core competencies to produce a wide range of diagnostic and research products. Partners as an active member of the RTD OPS leadership team with responsibility for assisting the Vice President, Manufacturing, Ventana-Roche Tissue Diagnostics. Participates in or leads Global projects, as required.
•Leads all aspects of Instrument Manufacturing Operations Management, including manufacturing, standard cost achievements, instrument performance and reliability, P&L achievements, budget creation and execution and overall team development.
•Fully accountable for Instrument field quality issues due to manufacturing and partners cross-functionally to drive and achieve required improvements.
•Develops and executes long-term Instrument manufacturing strategy while managing short-term objectives and volatility.
•Crafts, manages and implements all Instrument capacity optimization and expansion needs. Provides vision and direction to the manufacturing team in order to ensure attainment and alignment of aggressive growth strategy
•Establishes new technology competencies to achieve process excellence and to meet long-term market competitiveness needs.
•Works effectively with R&D and Life Cycle teams to ensure the smooth and successful transfer/scale-up of new products into manufacturing as well as their commercial launch
•Manages production schedules for required materials to achieve highest customer satisfaction metric on time and full.
•Directs the manufacturing managers to define and document processes and procedures used to assemble and test products, resolve any problems and provide quality products to the company’s customers.
•As a member of the local Site leadership team; ensure the culture of the company remains at the forefront of all business decisions. Participates in quarterly business reviews and take action as necessary to ensure the success of the company.
•Prepares and manages budgets and resources.
•Maintains effective liaison with all interfacing departments and outside suppliers to provide optimum operations success.
•Implements and maintains FDA standards. Audits and reviews certification of all products to ensure they meet specifications and regulatory requirements.
•Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
Bachelor's Degree in mechanical engineering field required.
Master's Degree in mechanical engineering/business field preferred.
10 years of manufacturing leadership with a world class manufacturing organization. Including 7 years of industrial experience in biotechnology or medical diagnostics is required.
A prior product transfer knowledge would be highly preferred.
Knowledge, Skills or Ability:
•Must have Lean Manufacturing knowledge and help the Company apply it in a lean process environment.
•Proven ability in leading efforts in the transfer and scale up of products from R&D to manufacturing and commercialization.
•Must have strong technical and management skills. Including excellent written and oral communication.
•Extensive experience in capacity strategy, GMP facilities planning and state of the art manufacturing methods is essential.
•Prior management of a world class manufacturing organization in an FDA regulated environment.
•Understanding of compliance with the FDA and ISO guidelines is critical and will be a significant element of responsibility. Must be highly organized and detail oriented.
•Excellent cross-functional team leadership and participation skills. With demonstrated ability to lead and motivate others.
•Excellent troubleshooting skills
•Results and goals oriented.