Sr. Scientist, Design Transfer

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

We advance science so that we all have more time with the people we love.

GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche’s commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world’s #1 provider of diagnostics, the Roche Group offers an unrivaled experience in developing and commercializing tests that enable personalized treatment strategies for patients. 

• You will acquire and apply the DQM mindset through training, mentoring, and process improvement.

• You will initiate and sustain a sense of urgency in working cross-functionally by sharing both success stories and lessons learned.

• You will focus on metrics that influence behavior in Operations, R&D, and other functions across GenMark.

• You will focus on manufacturability and process capability to minimize delays, reworks, and non-conformance.

• You will be engaging with R&D assay design teams early and throughout the development cycle to drive collaboration with operations and to define and implement DQM tools such as Critical to Quality Scorecards for process capability analysis, FMEA risk analysis, identification of Critical to Quality Attributes and Critical Process Parameters.

• You will establish a database to track and trend results from R&D assay design teams for use as a tool when setting specification limits/criteria for in-process test methods and/or final QC testing.

• You will drive activities in collaboration with supply chain to procure new raw materials and/or vendor qualification.

• You will be accountable for transferring new product BOMs, formulations, manufacturing work instructions, and test methods.

Who You Are:

(Required)

• You have a B.S. degree in life sciences, engineering or scientific discipline with 5+ years of related experience; or a MS degree in life sciences, engineering or scientific discipline with 2+ years related experience

• You have a minimum 2+ years industry (diagnostics) experience working independently and cross functionally with internal and external stakeholders

• You have demonstrated design transfer experience in a FDA regulated environment, preferably in IVD product development

Preferred:

• You have demonstrated comprehension and extensive hands-on experience with: mathematical calculations involving chemical and/or reagent formulations, PCR assays, and other current molecular biology techniques.

• You have experience with problem solving using an analytical approach to resolve problems.

• You have experience gathering, organizing, and analyzing information from multiple sources.

• You have the ability to pivot and handle multiple priorities to develop alternative solutions.

• You have in-depth experience with process and product validations, specification setting and test method validations, and FDA design control documentation is required.

• You have working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.

• You have an accuracy focused approach to documentation and data analysis.

• You have the ability to be proactive in influencing peers to create a decision making environment that is collaborative, positive, and constructive.

• You have effective time management skills in order to consistently deliver on schedule.

• You have experience leading design transfer activities for medical devices in international markets.

• You have experience with Design for Quality and Manufacturability (DQM).

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility w