Scientist, Product Transfer

Combine molecular biology knowledge with a technical understanding of Cepheid systems to play a key role within the Product Transfer group.

Work together with Manufacturing, Quality, Regulatory and Materials Planning / Logistics departments to ensure the transfer of new products and processes and the continued production of cost-effective quality products.

Identify and implement new, streamlined or improved processes into production.

Responsibilities :

Leads projects to ensure the continued production of cost-effective quality products and streamline processes.

Successfully implements post-launch product improvements in production, including improvement and validation of test methods, training of personnel, and implementation of all supporting documentation (BOMs, SOPs, worksheets, Design History, etc.).

Drives, designs, and performs experiments in support of validation / qualification activities and process improvement projects.

Performs testing of biological / chemical assays, as needed, to support ongoing project activities and goals. Analyzes data and participates in root cause analysis and design of solutions.

Writes reports compliant with FDA regulations.

MINIMUM REQUIREMENTS :

Education or Experience :

Bachelor’s degree with 2+ years of related work experience OR

Master’s degree in field with 0-2 years of related work experience.

Knowledge and skills :

Proficiency in molecular biology techniques including real-time PCR

Proficiency in Microsoft Excel and highly agile in all other basic MS Office software. Proficiency in the management / sorting / filtering / manipulation of large amounts of data in Excel spreadsheets.

Excellent organization and communication skills.

Ability to successfully interact with multiple departments. Demonstrate strong ethics and teamwork.

Ability to handle multiple projects simultaneously, with tight timelines, and progress independently in a timely manner.

Physical requirements / abilities :

Ability to work in an office, laboratory, and production environment.

PREFERRED REQUIREMENTS :

Bachelors + 2-4 years of experience, Master’s degree in Life Science +2 years of experience, or Ph.D, or equivalent combination of education and experience to perform at this level.

Hands-on experience in Operations functions, including a solid understanding of batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, ERP systems, etc.

Practical understanding and use of statistical techniques for data analysis.

Experience with molecular diagnostic assays.

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.