Manager, Product Transfer

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The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity

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 Manager, Product Transfer position is responsible for leading the transfer of newly developed assays from R&D to manufacturing. This position will be instrumental in leading key decision makers in a matrix environment between the R&D departments and the commercial manufacturing operations.

• You will be responsible for transferring and validating assay formulations, QC methods and testing processes into manufacturing; you will be responsible for creating and approving Product BOMs, Specs, Work Instructions and other documentation as the Design Transfer Lead for new assay introductions.
• You will drive, define and build-in business requirements and manufacturability requirements into the new product’s design transfer processes.
• You will design and oversee appropriate stability studies for any new raw materials and/or formulations required for newly developed products, ensuring robust performance; you will lead QC development and implementation for new assays and underlying components.
• You have extensive biochemical knowledge and hands-on experience pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques.
• You have excellent Project Management successes with expertise influencing key decision makers within a matrix environment
• You will act as a catalyst and primary contact for multiple functional areas across project teams, present to senior management project status, plans, issues and recommendations as well as negotiate key stakeholders including Quality, Regulatory, Assay Development, and Operations.

This position is located on-site in Carlsbad, CA & Torrey Pines, CA. There are no relocation benefits for this position.

Who You Are: (Required)

• You have a PhD or Master’s degree in a biology, chemistry or scientific discipline, with 10+ years of experience in the healthcare/biotech/pharmaceutical industry
• You have experience in design transfer from product development to commercial manufacturing processes in the biotechnology arena, preferably in an FDA regulated environment
• You have demonstrated, in-depth experience with process and product validations, specification setting and test method validations, and FDA design control documentation
• You have demonstrated leadership and project management experience within a matrix environment

Preferred:

• You have experience in molecular diagnostics product development
• You have experience leading design transfer activities for medical devices in international markets
• You have six sigma Green belt or Black Belt, and project management certifications
• You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities
• You have strong written and verbal communication skills; including the ability to communicate with all levels within the organization.
• You have experience working collaboratively, fostering professional and constructive relationships as part of a team; while also working independently to produce data and meet challenging timelines and goals

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 & Torrey Pines, 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 $111,700 - $207,400. 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

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.