Summary

Responsible for facilitating the transition of products from Development to Manufacturing as a member of the Assay Transfer team.  Initiates, directs, and executes process characterizations, scientific research, development and manufacturing process strategies to support new and existing reagent products. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems to ensure manufacturability and improve processes. Plans and executes laboratory research as it pertains to process characterizations or other manufacturing matters. Maintains broad knowledge of state-of-the art principles and theories. Prepares manufacturing documents and completes transfer activities for new products.  Makes contributions to scientific literature and conferences. Serves as an in-house and outside consultant on design transfer. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways.

Responsibilities

Represents Assay Transfer on cross functional project teams.

Conducts research and development activities for products, methods and/or processes to ensure manufacturability.

Works independently with high level direction provided by senior technical staff, management or project leader.

Focuses on delivering efficient, sustainable process to local and global Roche Manufacturing Operations.

Participates in efforts and shares ideas to define new components, products, or processes associated with manufacturing.

Identifies technical challenges and offers solutions.

Makes suggestions to improve work processes within Assay Transfer and Roche Tissue Diagnostics.

Collaborates closely with both Development and Operations to ensure smooth transition of new products.

Prepares and delivers presentations to own or other groups.

Creates potentially patentable components for systems, reagents or processes.

Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques.

Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements.

Applies advanced scientific knowledge to projects.

Executes experiments; drives experimental design.

Utilizes appropriate statistical tools (ex. DOE, Cpk analysis, Gage R&R).

Trains others in areas of expertise, May supervise lower level personnel

Participates in project planning and process updates

Monitors work to ensure quality, and continuously promote Quality First Time

Qualifications

Bachelor’s Degree in Scientific field with 8 years relevant experience OR

Master’s Degree in Scientific field with 3 years relevant experience OR
Ph.D. in Scientific field entry level

Knowledge, skills and abilities

Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought.

Strong understanding of scientific principles and concepts.

Some knowledge of manufacturing processes preferred.

Experience with lean concepts and design for six sigma preferred.

Applies advanced technical writing skills to produce reports and documents.

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