Sr. Scientist, Design Transfer
Sr. Scientist, Design Transfer
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$ 94000 - 175000
1 Vacancy
Job Description
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 worldclass solutions for multiplex testing with enhanced features that contribute to Roches commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the worlds #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 crossfunctionally 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 nonconformance.
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 inprocess 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 handson 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 indepth 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 onsite 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 $94000 $175000. Actual pay will be determined based on experience qualifications geographic location and other jobrelated 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.
#genmark2025
Who we are
GenMark is now a proud member of the Roche Group more than 100000 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. GenMarks ePlex true sampletoanswer system offers unique solutions to address the most significant challenges facing clinical laboratories while supporting hospital systems to deliver patientcentered valuebased care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sampletoanswer solution designed to improve patient care reduce costs and increase lab efficiency. GenMark is headquartered in Carlsbad California.
GenMark is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.
If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.
Required Experience:
Senior IC
Employment Type
Full-Time
