Technical Transfer Speclialist

4 weeks ago

Tucson, Arizona, United States Roche Full time
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

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 Technical Transfer Specialist will assist in coordination between Operations and the Development, Regulatory and Project team at Roche while launching new Assays, Reagents and Bulk materials used in tissue diagnostics. This position helps to ensure that all Operations needs are met from a manufacturability, quality, cost and schedule perspective. The application of program management skills, LEAN manufacturing principles, process engineering and sound scientific rigor are essential to ensure that new Assays, Reagents and Bulk materials are introduced into the existing manufacturing processes. This position helps to ensure that the requirements for a minimum viable product are met within Operations and clearly communicates project risks and proposes gap closure plans to eliminate these risks. This position will also support, as needed, the transfer of products from site to site or site to supplier within the US.

The Opportunity:
  • You are developing a basic understanding of reagent manufacturing best practices at the site and provide support to operations functions
  • You are coordinating with Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing and Label Control) to ensure new products are moved into the manufacturing process per the transfer plan
  • You are supporting the refinement of Technology Transfer standard work to continuously improve the transfer process
  • You are supporting creation of project plans to track and ensure timely completion of transfer projects
  • You execute Validation protocols utilizing Good Manufacturing Processes (GMP) and standards for transferred products.
  • You are developing familiarity of site manufacturing processes to promote and improve GMP

Who you are?
  • You hold a Bachelor's Degree in an Engineering/Engineering Technology or Life Science discipline (Master's Degree preferred) and 1-3 years of related experience with a Bachelor's Degree (Equivalent combination of education and/or experience may be accepted upon management and HR review)
  • You have demonstrated potential for technical proficiency, scientific creativity, collaboration with others, and independent thought
  • You have basic understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to production
  • You're advanced in technical writing skills to produce reports and documents
  • You're able to apply 6 Sigma and Lean Manufacturing Methods during the development phase
  • You're able to utilize systems such as SAP and ETQ (preferred)

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Indianapolis is 59,200.00 and 110,000.00 USD Annual. 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

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

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.

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.

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