Job Description

POSITION SUMMARY:

Product Transfer Specialist represents Manufacturing/Operations in cross-functional core teams for Cepheids Bothell molecular reagents development, product sustainment, and process improvement. This person will be the technical partner to the R&D, Development, and Manufacturing teams throughout the life cycle of new and legacy products. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, and other functions within Cepheid is expected.

ESSENTIAL JOB RESPONSIBILITIES:

* Actively participate in the development of new products as a representative of Technical Operations to ensure compatibility with current and future manufacturing processes and capabilities.
* Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products. Conduct design for manufacturability (DFM) review meetings routinely.
* As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, reference material, reagent formulation, and product or consumables testing
* Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production:
* production scale-up
* process development/optimization
* technology transfer
* process validation
* test method validation
* SAP extension and costing
* Develop and maintain production documentation including procedures, worksheets, and bills of materials.
* Uses in-depth of manufacturing and assay knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation. Assists junior team members in troubleshooting.
* Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.
* Leads smaller teams of product transfer associates or functional teams in the execution of complex projects.
* Serves as a mentor to junior team members during project execution
* Actively consults with other manufacturing teams as an assay subject matter expert to improve products, processes or services.

TRAINING RESPONSIBILITIES: (REQUIRED)

* Complete all assigned and required training satisfactorily and on time
* For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

MINIMUM REQUIREMENTS:

Education and Experience (in years):

* Masters or Ph.D degree in Life Science, Biochemistry or Chemistry, or equivalent combination of education and experience to perform at this level.
* 7 years experience working in manufacturing engineering, product transfer, or process development discipline in a scientific or engineering industry

Knowledge and skills:

* Deep knowledge of Real Time PCR
* Experience with chemistry, and or molecular biology in a development or production environment
* Ability to work effectively with cross-functional core teams
* Experience within operations/manufacturing
* Experience with Design for Manufacturing
* Experience in chemistry or protein reagent development.
* Experience with Quality System Regulations.
* Experience with ERP and Change control systems
* Familiarity with infectious disease or cancer biology.

Physical requirements/abilities:

* Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.

PREFERRED REQUIREMENTS:

* Experience with SAP and Agile systems

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.