Senior Manager, Manufacturing Sterilization Operations

Requisition ID : 32357

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells.

With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve.

Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference.

Join us and help shape wherever we go next. You create your future and ours.

We are seeking an experienced Senior Manager, Sterilization Operations to lead our EtO sterilization team. The ideal candidate will have a strong background in Ethylene Oxide (EtO) sterilization processes, ensuring compliance with regulatory standards and optimizing operational efficiency.

This role demands a strategic thinker with exceptional leadership skills to oversee daily operations, drive continuous improvement initiatives, and manage a dedicated team of professionals.

Join our dynamic organization to contribute to the delivery of safe and effective healthcare products, while advancing your career in a cutting-edge environment.

ESSENTIAL DUTIES

• Manages cross-organizationally with Terumo Blood and Cell Technologies (TBCT) Corporate and other Terumo sites to meet strategic goals and service expectations.
• Ensures compliance to regulatory requirements in the sterilization industry to include : CDPHE, EPA, OSHA, etc.
• Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Works with internal and / or external resources to resolve problems of exceptional complexity and sensitivity.
• Recommends, implements, and drives changes to operating policy within and outside area of responsibility, supporting internal and external customers.
• Influences heavily short and long-term business goals and corporate objectives.
• Coordinates and leads regulatory and certification inspections as well as communications with regulatory agencies. Acts as management with executive responsibility to regulatory bodies.
• Manages supplier base including improving the quality and delivery of suppliers.
• Works with industry groups, elected officials, and governmental personnel to advance company interests.
• Manages intercompany contracts associated with products and services.
• Producesand supports technical training programs.
• Directs the development and management of budget for area of responsibility.
• Manages and provides direction to production, quality, engineering, local supply chain, planning and other leaders in support of the achievement of business objectives.
• Participates in the short- and long-term planning process that establishes objectives for local operations and commercial objectives.
• Responsible for creating and tracking the factory budget including cost estimation, staffing, and timelines.
• Communicates on all levels with senior management, including technical, strategic, and business.
• Identifies project and new process opportunities and is able to articulate value and risk of opportunities.
• Utilizes technical skills to evaluate proposed design, adaptations, and modifications to sterilization processes.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum 10 years experience.
• Experience in managing, directing, and planning in a sterilization environment preferred.
• General Manufacturing Operations experience preferred.

Skills

• Demonstrated ability to communicate effectively both verbally and in writing.
• Broad theoretical knowledge of management, quality, regulatory affairs, and manufacturing.
• Requires working knowledge of the Business's products and uses.
• Demonstrated effective leadership, managerial, and strategic planning skills.
• Supervises management, maintenance, and integrity of Quality Systems, including regulatory compliance and the corrective and preventive action process.
• Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application to meet the service and information needs of customers and management.
• Requires exceptional understanding of financial performance reports and their implications in own and other areas.
• Business focus and understanding of customer needs, product technology, technical support, usage, and user markets and the ability to determine appropriate actions.
• Extensive knowledge of U.S. and international sterilization regulations and standards.
• Thorough understanding of measures of customer satisfaction and experience in their implementation as a tool for continuous improvement.
• Demonstrated knowledge of sterilization operations, process validation, engineering, tactical execution, customer service, professional communications, cross functionality, problem solving, strategic reasoning, teamwork, change management, business acumen and business ethics.
• Demonstrated expertise in planning, budgeting, and project management toward achievement of annual, long term, and strategic business objectives.

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include : reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range : $73.00to$91.00- Hourly pay rateto be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base : 20.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.

Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.

To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.

For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.

S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.

• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
• Respect - Appreciative of others
• Integrity - Guided by our mission
• Care - Empathetic to patients
• Quality - Committed to excellence
• Creativity - Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces,and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.