Operations Transfer Coordinator

2 weeks ago

Tucson, Arizona, United States Planet Pharma Full time

JOB SUMMARY:

The Operations Transfer Coordinator will facilitate collaboration between the Operations and Development, Regulatory, and Project teams during the introduction of new Assays, Reagents, and Bulk materials utilized in tissue diagnostics. This role is crucial in ensuring that all operational requirements are addressed from a manufacturability, quality, cost, and scheduling standpoint. Employing program management skills, lean manufacturing principles, process engineering, and rigorous scientific methodology is essential for the successful integration of new Assays, Reagents, and Bulk materials into existing manufacturing workflows. This position also plays a key role in confirming that the criteria for a minimum viable product are satisfied within Operations and effectively communicates project risks while proposing solutions to mitigate these risks. Additionally, this role may involve supporting the transfer of products between sites or from sites to suppliers within the United States.

Key Responsibilities:

  • Comprehend and convey manufacturing best practices at the site while communicating essential requirements to the core project team to ensure manufacturability and scalability.
  • Act as the primary Operations project contact, ensuring that the needs of all Operations stakeholders (Manufacturing, Process Engineering, Validation Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing, and Label Control) are recognized and communicated throughout the transfer process.
  • Acquire and apply Technology Transfer standard procedures to continuously enhance the transfer process.
  • Utilize project management techniques to plan, monitor, and ensure the timely completion of transfer projects.
  • Gradually develop expertise in site manufacturing processes to promote, train, and enhance Good Manufacturing Practices (GMP) at the site, ensuring successful transfer activities from cost, quality, and delivery perspectives.
  • Incorporate manufacturing requirements into development projects to guarantee a robust technical transfer into operations by providing input during the design phase for manufacturability.
  • Execute Validation protocols with assistance from other Technical Transfer Specialists, adhering to Good Manufacturing Processes (GMP) and standards for transferred products.
  • Engage in cross-functional teams to ensure that the needs of the technology transfer project are met, establishing partnerships across other organizational groups (Lifecycle, Regulatory, and other business partners) as necessary.
  • Identify and troubleshoot issues, participate in transfer planning and process updates, and prepare and deliver presentations of project outcomes to diverse audiences.
  • Perform additional duties as assigned by management.

ADDITIONAL RESPONSIBILITIES:

Responsibilities may include collaborating with leadership and team members in various project coordination and planning activities, such as:

  1. Maintaining resource and task activity sheets.
  2. Scheduling and facilitating planning meetings.
  3. Monitoring and coordinating project assignments and timelines.
  4. Identifying resource and priority conflicts.
  5. Participating in workflow standardization and implementing efficiency projects.
  6. Maintaining best practices.
  7. Exploring and applying project management tools.

QUALIFICATIONS:

To excel in this role, an individual must satisfactorily perform each responsibility. The requirements listed below represent the knowledge, skills, and abilities necessary for success. Reasonable accommodations may be made to enable individuals with disabilities to fulfill these responsibilities.

Formal Training/Education:

Bachelor's Degree in Engineering/Engineering Technology or Life Science discipline with 1-3 years of experience, or a Master's Degree in 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, and independent thought.
  • Basic understanding of assay, bulk, and reagent manufacturing processes and design, with the ability to apply scientific methods relevant to production.
  • Advanced technical writing skills for producing reports and documentation.
  • Ability to apply Six Sigma and Lean Manufacturing methods during the development phase.
  • Proficiency in utilizing systems such as SAP and ETQ.

Pay Rate: $27-32/Hr *Salary will be commensurate with candidate experience

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