Senior Specialist, 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 Senior Specialist, Product Transfer (Sr. Specialist) facilitates the transfer of new assays from R&D into manufacturing. The Sr. Specialist must exercise technical discretion in the design, execution and interpretation of experiments to ensure the product design can be manufactured with high capability.

The Sr. Specialist partners with the R&D and manufacturing teams to assess manufacturability throughout the life cycle of new assay products using professional concepts to contribute to the achievement of company objectives in creative and effective ways. The Sr. Specialist will use working knowledge of scientific principles, manufacturing processes, and scientific creativity to identify and implement improvements for new product introduction activities, including bill of materials, reference material, reagent formulation, and product or consumables testing.

• You will work with assay and/or manufacturing teams to transfer and validate reagent formulation, consumable manufacturing and QC methods; You will design and perform raw material, reagent and component stability testing; You will prepare reagents and solutions as needed, using appropriate procedural and documentation methods, including industry standard good laboratory practices
• You will work with a Project Manager to develop plans and timelines for all transfer activities; You will work in a multi-disciplinary team with other scientists, chemists, engineers, Operations, QA, and QC personnel
• You will create and approve product- Bill of Materials (BOMs), specs, work instructions and other documentation under the direction of the Product Transfer Manager
• You have a demonstrated understanding of Materials Resource Planning (MRP) systems and ERP systems
• You will provide product stability claim substantiation to ensure efficacy and safety of new and existing products; You will prepare documents meeting company standards, including data summaries, reports, SOPs and procedures
  
  

This position is located on-site primarily in Torrey Pines, CA and Carlsbad, CA.

There are no relocation benefits for this position.

Who You Are:

(Required)

• You have a Bachelor’s or Master’s degree in Biochemistry, Molecular Biology, Analytical Chemistry or a related field with 5 years of molecular biology or biochemistry laboratory experience
• You have demonstrated the ability to define and solve problems; with proven organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple change projects and priorities
• You have demonstrated mastery in data analysis, research design, and evaluation of new techniques & procedures for products, systems or technologies; you have substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies
  
  

Preferred:

• You have excellent time management skills and ability to work independently with minimal direction
• 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 Torrey Pines, CA and Carlsbad, CA.

Relocation benefits are not available for this position.

The expected salary range for this position based on the location of Carlsbad, CA is $71,500 - $132,900. 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.

Roche 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.