QC Stream Lead / Principal Scientist – Continuous Glucose Monitoring

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Doing now what patients need next. 

Near Patient Care is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.
 

Internal Manufacturing Indianapolis is a function within Roche Diagnostics - Near Patient Care Operations, responsible for the strip manufacturing of the majority of our blood glucose monitoring portfolio for the global demand of our patients.  In the future, Internal Manufacturing Indianapolis will also be responsible for sensor manufacturing for our continuous glucose monitoring portfolio.

The Opportunity

• You manage complex Quality Control methods development and technical transfer projects. You are responsible for developing and delivering all Quality Control aspects in addition to lab equipment for an entire manufacturing process area including facility preparation, equipment installation and validation, operations readiness, safety, and other areas.  

• You will be the coordinator and single point of contact for delivering the QC value stream for the technical transfer of a CGM product.  You are responsible for overarching ramp-up progress and success within your workstream.  

• You are responsible for the delivery of an entire Quality Control space and processes (i.e. Value Stream).  You will be the single point of contact and responsible for setting up the Quality Control processes for a value stream, which will include a variety of test methods, all the supporting lab equipment, facilities, staffing, etc.

• You will lead a cross functional team with representatives from all necessary supporting areas including Facilities, Engineering, Operational Technology, Manufacturing, Safety, Health & Environmental, Procurement, Finance, and others.  The QC Stream Lead may coordinate the work of multiple teams, in addition to coordination of other business aspects. You ensure the space, lab equipment, all operations readiness topics including staffing and ancillary topics, and all supporting functions are ready for delivery at the start of production.  

• Prior to launch, you support Stream Leads develop and maintain project timelines, budgets, quality goals, and deliverables.  After launch, you may take a high level individual contributor role with these responsibilities.

• You interface with and provide updates to the overall Program Lead and represent the work stream to the upper level and within ramp-up meetings.

• You are responsible for knowledge transfer and global collaboration between Indianapolis and Mannheim Internal Manufacturing organizations.

• You coordinate capital needs with the CapEx Manager, track project spend vs budget and create transparency of overall status within the work stream

• You drive the coordination of internal manufacturing team member assignments to various program needs (i.e. support access to the right resources in alignment with the project priorities).

Who You Are

• You have a  Bachelor’s degree in a closely related scientific/technical discipline (Analytical Chemistry, Biochemistry, Chemistry, Biology, Engineering) or equivalent.

• You have 8+ years of work experience in a related field. We will consider equivalent combination of education and work experience.

• You have deep knowledge of Test Method Validation, Lab Equipment