Technical Transfer Engineer

Our partner ranks among the world’s prominent corporations in the biotechnology industry. Working on their team means you’ll impact the lives of millions of patients and be a part of a culture of innovation, curiosity, and diversity.

JOB SUMMARY - THIS IS A HYBRID POSITION IN THE TUCSON, AZ AREA

The Technical Transfer Specialist will assist in coordination between Operations and the Development, Regulatory and Project team at Roche while launching of 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 help 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.

Responsibilities

• Understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability

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

• Learn and apply Technology Transfer standard work to continuously improve the transfer process

• Support the use of project management techniques to plan, track and ensure timely completion of transfer projects

• Overtime, develop an 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

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

• Execute Validation protocols with assistance from other Technical Transfer Specialists and utilize Good Manufacturing Processes (GMP) and standards for transferred products

• Participates in 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

• Other duties as assigned by management.

ADDITIONAL RESPONSIBILITIES:

Include working with leadership and team members in assisting with various project coordination and planning activities, example :

1) Help maintain the resource and task activity sheets,

2) Schedule and facilitate planning meetings,

3) Monitor and coordinate project assignments & timelines,

4) Identify resource and priority conflicts,

5) Participate in workflow standardization and implement efficiency projects,

6) Help maintain best practices

7) Explore and apply project management tools

QUALIFICATIONS

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

Education Level Education Details

Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experience

Master's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 0-2 year of experience

Knowledge, Skills and Abilities

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

• Basic 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

*Solü Technology Partners provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability or genetics.