ICU Medical Senior Director, MS&T, R&D and Validation in Austin, Texas
FLSA Status: Exempt
• Act as the go-to technical expert for the Solutions BU and the commercial team
• Establish and maintain Research and Development (R&D) and Technology capabilities for ICU Medical
• Lead the technical aspects of Manufacturing Service Agreement exit planning, including relevant process transfers and/or outsourcing
• Lead important technical or R&D projects for the business development
• Lead Program Management Office in IV Solutions to identify, evaluate, and provide technical oversight to CMOs/CDMOs
• Establish and maintain a Manufacturing Science and Technology organization which provides direct support to commercial pharmaceutical manufacturing operations by supplying direct technical expertise towards troubleshooting, process monitoring, compliant reversal of financially reserved commercial material, and corrective and preventive action identification
• Provide technical guidance for process, cleaning, automated process control, equipment, and sterilization validation organization to ensure the IV Solutions BU remains compliant with cGMP requirements for its validated systems
• Lead technical organizations of the IV Solutions business to identify, evaluate and implement potential process improvements.
• Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting.
• Implementing changes to procedures and creating documentation for changes to manufacturing processes.
• Manage project activities through provision of oversight and guidance.
• Preview/provide feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.
• Contribute to longer term portfolio and strategic planning for the IV Solutions BU.
Essential Duties & Responsibilities:
• Establish, recruit, and maintain a science and technology organization to address the technical challenges facing the IV Solutions BU in the areas of manufacturing science (process science), and research and development.
• Provide technical support for equipment and process validation activities. Lead evaluation of new process technologies, and process specifications to define the scope of capital projects.
• Lead technical process organizations (R&D, MS&T) to implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
• Provide technical resources to support evaluation of strategic technical investments or projects of the IV Solutions BU.
• Provide support for: discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures.
• Assist validation organization in maintaining the cGMP compliance of the IV Solutions BU with respect to process, cleaning and APCS validation requirements
• Support product supply and supply chain robustness by generating data to support vendor changes, qualifying alternate suppliers, and providing technical guidance during the due diligence process for new suppliers.
Knowledge, Skills & Qualifications:
• Establish and implement business strategies with a longer-term focus (typically 3 to 5 years) based on the organization’s vision.
• Significant frontline or primary impact on the results
• Come to agreement by managing communications through discussions and compromise. Issues are short-term operational, mid-term tactical, or limited strategic in nature
• Internal Divergent Interests: Conflicting objectives that inhibit reaching a solution within the company
• Change significantly by enhancing entire existing processes, systems, or products
• Understanding that problems and issues are truly multi-dimensional requiring end-to-end solutions with direct impact on all three Dimensions – Operational, Financial and Human
• Mastery of a specific professional discipline combining deep knowledge of theory and organizational practice or expertise across several different disciplines within a function or several different job areas across functions
Education and Experience:
• Master’s Degree required; PhD in relevant scientific or engineering field preferred.
• Minimum of 15 years of experience required; 15 years of industry experience with 5 years staff management experience in an advanced area and 5 years of pharma experience with a good understanding of the regulatory requirements within the pharmaceutical industry preferred.
• Deep understanding of program management required.
• Demonstrated ability to effectively communicate complex scientific information to non-specialists required.
• Experienced in evaluating site’s business priorities and conceiving, selecting, and prioritizing scientific and engineering projects to address priorities a key success factor.
• Must be at least 18 years of age
• Typically requires travel 5-20% of the time
• Domestic Responsibility (A single country or multiple countries when knowledge of local culture is not required to perform job functions.)
Physical Requirements and Work Environment:
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Title: Senior Director, MS&T, R&D and Validation
Requisition ID: 20300492