Connect to a Career That Makes a Difference Job Description -
Senior Director, MS&T, R&D and Validation (20300492)
Senior Director, MS&T, R&D and Validation - ( 20300492
FLSA Status: Exempt
• Act as the go-to technical expert for the Solutions BU and the
• 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
• Lead important technical or R&D projects for the business
• 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
• 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
• Preview/provide feedback and technical/scientific support on
any project deliverable, i.e. remediation strategy, plan reports,
• Contribute to longer term portfolio and strategic planning for
the IV Solutions BU.
• 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
• 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
• 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
• 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