Process Specialist

Job Title: Technical Transfer Specialist

Location: Tucson, AZ

Duration: 12+ months

Pay Range: $27-32/hr. on W2.

About Client:

An innovative company specializing in medical devices excels in developing, manufacturing, and marketing sophisticated instrument reagent systems designed to automate tissue and slide staining processes in anatomic pathology laboratories. Their advanced products play a crucial role in aiding the diagnosis and treatment of cancer and infectious diseases.

Job Summary:

The Technical Transfer Specialist will assist in coordination between Operations and the Development, Regulatory, and Project teams 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 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.
• Over time, develop 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 perspectives.
• 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, for example: 1) Helping maintain the resource and task activity sheets, 2) Schedule and facilitating 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.

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 years 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 the 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