Sr. Scientist, Design Transfer

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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 where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

This position is based on-site in Carlsbad, CA. (This is not a hybrid position.)

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of Carlsbad, CA is $94,000 - $175,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

#genmark2025

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.