In this key role within our Scientific Affairs organization, this Manager will have the opportunity to significantly influence and contribute to the scientific direction and future of the Company’s blood safety technologies. Serving as the thought leader in this space, you will be responsible for the development and implementation of scientific strategies which advance the company’s objectives, drive product innovation and ultimately enable Terumo BCT to serve more patients world-wide.
It’s an exciting time for Terumo BCT and in this role, you will have the opportunity to contribute directly to the development of new and existing technologies through the engagement of internal and external thought leaders and serving as a liaison between science, clinical, engineering, manufacturing, marketing and regulatory teams to achieve excellence in product development, verification, validation, regulatory approval, and market adoption.
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.
Takes responsibility for design of studies during the research, development and pre-clinical phase of a product and conducts studies according to regulatory requirement.
Outstanding technical, communication and project management skills as well as the ability to build strong relationships with key stakeholders in Commercial, Clinical, Regulatory and other relevant functions.
Provides scientific support across departments in the area of Pathogen Reduction. Works closely with senior management team and KOL’s to define scientific strategies that support business area objectives.
Partners with business area project leads to successfully implement projects or evaluate scientific or engineering related aspects. Determines resource requirements to support studies and resolves and/or escalates project-related issues in a timely fashion.
Authors and supports preparation of publications (abstracts, posters, manuscripts, marketing material). Includes clinical evaluation reports.
Understands customer issues and works to resolve problems with product, procedures, and policies that drive change where necessary to resolve these issues.
Comprehends short-term and long-term business goals.
Interfaces with industry representatives, customers and regulatory agencies on product development.
Supervises, mentors, and develops direct reports
MINIMUM QUALIFICATION REQUIREMENTS
PhD or M.S. in Immunology, Cell Biology, Infectious Diseases or related fields preferred. Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 6 years experience.
Experience in a leadership role required.
Knowledge and use of relevant PC software applications and skills to use them effectively.
Demonstrated ability to communicate effectively both verbally and in writing.
Demonstrate effective leadership, management, cross-functional team skills, self-direction, and ability to work independently.
Serves as content expert on therapy, clinical applications, the scientific basis and mechanics (how devices work). Maintains state-of-the-art knowledge by attending relevant meetings and visiting key opinion leaders and investigators.
Subject Matter Expert of scientific and engineering studies and regulatory requirements.
Understands medical statistics and experimental design.
Must have a positive and proactive approach to identification and definition of problems, leading to proactive development and implementation of solutions.
Must be constructive and have a relentless pursuit for solutions while motivating others to do the same.
Demonstrate interpersonal skills and the ability to represent the business with both internal and external contacts.
Requires a high level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions.
Must be able to work independently on assigned issues and be resourceful in developing tests and assays.
Must be able to use outside resources as needed to do tests and experiments when in-house resources are not available.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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.
Additional Physical Requirements
Ability to travel based on business need.
About Terumo BCT
Terumo BCT, Inc. is a ~$1Bn, growing global leader in technologies to enable safe blood and cell collection, regenerative medicine and the manufacture of cell therapy blood components. With the unique combination of expertise in apheresis collection, manual and automated whole blood processing, and pathogen reduction, Terumo BCT believes in the potential of blood and cellular therapies to continue to advance patient care beyond what it does today. It’s this belief which inspires the company’s strategic plan to build a robust development platform which will enable the Company to double a $1B business to $2B.
Terumo BCT is a global company (> 60% revenue OUS) with the following four businesses or customer segments:
Blood Center Technologies:
Striving to make even safer, higher-quality transfusions available to more people
Advancing blood therapies to bring more treatment options to patients
Cell Processing Technologies:
Automating the cell manufacturing process to advance tomorrow’s therapies
Helping clinicians harness the biologic potential of patients’ own cells