Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
We advance science so that we all have more time with the people we love.
Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.
The Senior Project R&D Manager will plan and drive execution of cross functional projects with Product Development, Equipment Engineering, Product Maturity, Quality Assurance and other areas within the company. This individual will develop and document detailed technical work breakdown structures, sprints, project GANTT, resource plans, technical goals and budget, to deliver on project charters, business goals, and support delivery of superlative products for patients. This will be accomplished by interacting and providing effective leadership across cross-functional teams including Development, Engineering, Product Technical Support, Operations, Quality, and/or Regulatory.
- You will proactively identify and manage risks, critical path items, interdependencies, issues and delays, then work with team to develop risk mitigation and contingency plans to ensure projects remain on schedule and on budget; you will track and manage project and department FTE utilization and project consumable costs to budget.
- You will manage Design History File, Device Master Record, Technical Study Reports, and Design Changes; you will set and manage meeting agendas, minutes and action items.
- You will create and manage “Virtual Team Room” and electronic experimental study (DOE) repository for cross functional effectiveness of a large team of professional scientists and engineers working across product development and operations; you will prepare effective slide presentations and present progress to goals per plan at regular updates.
- You will support management of projects that encompass: development in R&D, manufacturing process development, scale-up, process validation, test method validations, equipment IQ/OQ/PQ, CAPAs.
- You will manage projects under QMS for kits, reagents, consumables (test strip/cartridge), instrument.
- You will support R&D, Operations and Project Leadership in helping to implement change management.
Education and Experience
- You have a B.S. degree in the biochemical / life sciences or bioengineering with 13+ years of experience in life science product development, process development and engineering / automation projects leading to product launches; you have Leadership executing, organizing, and influencing project teams in a matrix environment.
- You have 8+ years of experience and demonstrated success as a Project Manager in an In Vitro Diagnostics company, resulting in Product Launch and Process or Design Enhancements and/or Process remediation in context of at least class II, 510k, CE-IVD products.
- You have experience managing projects under QMS for kits, reagents, consumables (test strip/cartridge), instrument products.
- You have demonstrated experience with Class II medical device product development, design controls, ISO13485/cGMP; IVD and Point of Care / Disposable Consumable Assay Development experience.
- You have a demonstrated level of proficiency with Microsoft Office, Google Suite, MasterControl, SAP, Enterprise and project resource planning tools; you have experience developing detailed project plans using project management tools (SmartSheet, MS Project etc).
- You have demonstrated experience leading problem solving/root cause analysis.
Preferred:
- You are detail oriented and have demonstrated strong interpersonal skills.
- You have strong organizational and presentation skills and ability to solve ambiguous situations.
- You have the ability to work in a fast-paced, dynamic environment while juggling multiple projects.
- You have the following certifications: Agile, Scrum, LeanSix Sigma and/or PMP.
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 in Carlsbad, CA.
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location of Carlsbad, CA is $133,400- - 247,700. 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.
Who we are
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.
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