Operations Transfer Coordinator

2 weeks ago


Tucson, Arizona, United States Planet Pharma Full time

JOB SUMMARY:

The Technical Transfer Specialist at Planet Pharma plays a crucial role in facilitating collaboration between Operations and the Development, Regulatory, and Project teams during the launch of new Assays, Reagents, and Bulk materials utilized in tissue diagnostics. This position is vital in ensuring that all operational requirements are satisfied concerning manufacturability, quality, cost, and scheduling.

Key Responsibilities:

  • Communicate and implement manufacturing best practices at the site while conveying minimum requirements to the core project team to guarantee manufacturability and scalability.
  • Act as the primary Operations project contact, ensuring that the needs of all Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing, and Label Control) are understood and addressed throughout the transfer process.
  • Continuously enhance the transfer process by learning and applying Technology Transfer standard work.
  • Utilize project management techniques to plan, monitor, and ensure the timely completion of transfer projects.
  • Develop expertise in site manufacturing processes over time to promote, train, and enhance Good Manufacturing Practices (GMP) within the site, ensuring successful transfer activities from cost, quality, and delivery perspectives.
  • Incorporate manufacturing requirements into development projects to ensure a robust technical transfer into operations by providing input during the design phase for manufacturability.
  • Execute Validation protocols with support from other Technical Transfer Specialists, adhering to Good Manufacturing Processes (GMP) and standards for transferred products.
  • Engage in cross-functional teams to meet the needs of technology transfer projects, establishing partnerships across various organizational groups as necessary.
  • Troubleshoot issues, participate in transfer planning, and process updates. Prepare and deliver presentations of project results to diverse audiences.
  • Perform additional duties as assigned by management.

ADDITIONAL RESPONSIBILITIES:

Assist leadership and team members with various project coordination and planning activities, including:

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

QUALIFICATIONS:

To excel in this role, candidates must demonstrate the ability to fulfill each responsibility satisfactorily. The qualifications listed below represent the knowledge, skills, and abilities required:

  • Bachelor's Degree in Engineering/Engineering Technology or Life Science discipline with 1-3 years of relevant experience.
  • Master's Degree in Engineering/Engineering Technology or Life Science discipline with 0-2 years of relevant experience.
  • Demonstrated 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 related to production.
  • Advanced technical writing skills for producing reports and documentation.
  • Ability to apply Six Sigma and Lean Manufacturing methods during the development phase.
  • Familiarity with systems such as SAP and ETQ.

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



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