• Job Description

  Req#: 202311-125615

  The Position

  The Position

  The Senior Technical Transfer Specialist is the overall coordinator between Operations and the Development, Regulatory and Project team at Roche while launching of new Assays, Reagents and Bulk materials used in tissue diagnostic tests. This position is responsible for ensuring that all Operations needs are met from a manufacturability, quality, cost and schedule perspective.

  The application of program management skills, process engineering, lean manufacturing principles and sound scientific rigor are essential to ensure that new Assays, Reagents and Bulk materials are introduced into the existing manufacturing processes. This position ensures 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 to other US or international sites.
  

  Responsibilities

  • Define, understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability of Assays, Reagents and Bulks used in tissue diagnostics

  • Be the Global Operations project focal and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validation Engineering, Functional Leads, Quality, Validation, Planning, Purchasing, Procurement and Label Control) needs are understood and communicated through the transfer process

  • Actively establish and refine Technology Transfer standard work to continuously improve the transfer process. Actively seeks out, creates and implements new ways to drastically simplify our ways of working within the team

  • Define, lead and execute Validation protocols utilizing Good Manufacturing Processes (GMP) and standards for transferred products. Actively define and improve Validation standard work in coordination with the site Validations team to ensure uniformity across the organization.

  • Actively demonstrates project management techniques at an expect level to plan, track and ensure timely completion of transfer projects

  • Utilizes expertise in site manufacturing processes to promote, train and improve GMP within the site to ensure transfer activity is successful from cost, quality and delivery perspective

  • Effectively incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturing

  • Participates in and/or leads cross-functional teams to ensure the needs of the technology transfer project are met. Establishes partnerships across other organizational groups (Lifecycle, Regulatory and other business partners) as required

  • Troubleshoots problems. Participates in transfer planning and process updates. Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiences

  • Mentors, coaches and leads other Technical Transfer Specialists in the execution of projects and provides direct guidance and oversight to how other Technical Transfer Specialists operate

  • Demonstrates the ability lead complex, multinational projects and is able to navigate complex technical, regulatory and business. May be given Project Lead special assignments that require extensive coordination across the globe

  • Demonstrates the ability to work autonomously with minimal guidance or input

  • Other duties as assigned by management.

  WHO YOU ARE

  To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

  Formal Training/Education

  • Required: Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline

  • Preferred: Master's Degree BS in an Engineering/Engineering Technology or Life Science discipline

  Experience

  • Required: 5-8 years of related experience with a Bachelor's Degree

  • Preferred: 5-8 years of related experience with a Master's Degree

  Are equivalencies acceptable?

  • Yes, equivalent combination of education and/or experience may be accepted upon management and HR review
    

  Knowledge, Skills and Abilities Required:

  • Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought

  • Strong understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to production

  • Advanced technical writing skills to produce reports and documents

  • Ability to apply 6 Sigma and Lean Manufacturing Methods during the development phase

  • Ability to utilize systems such as SAP and ETQ

  • Demonstrated ability to lead, influence and coach team members

  • Ability to utilize systems such as SAP and ETQ preferred

  Licenses and Certifications

  • Have or be able to obtain PMP certification within 1 year
    

  Relocation assistance is not available for this opportunity.

  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 .

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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