Lead Technical Transfer Coordinator

1 week ago

Tucson, Arizona, United States Apollo Professional Solutions Full time
Job OverviewPosition Summary

Role Overview:

The Lead Technical Transfer Coordinator serves as the primary liaison between Operations and the Development, Regulatory, and Project teams during the introduction of new Assays, Reagents, and Bulk materials utilized in tissue diagnostic testing. This role is pivotal in ensuring that all operational requirements are fulfilled from perspectives of manufacturability, quality, cost, and timeline. The application of program management expertise, process engineering, lean manufacturing methodologies, and rigorous scientific principles is crucial for the successful integration of new Assays, Reagents, and Bulk materials into current manufacturing workflows. This position is also responsible for facilitating the transfer of products between sites or from sites to suppliers, both domestically and internationally.

Key Responsibilities:
  • Articulate, comprehend, and disseminate manufacturing best practices at the site while communicating essential requirements to the core project team to guarantee manufacturability and scalability of Assays, Reagents, and Bulk materials in tissue diagnostics.
  • Act as the Global Operations project point of contact, ensuring that the needs of all Operations stakeholders (Manufacturing, Process Engineering, Validation Engineering, Functional Leads, Quality, Validation, Planning, Purchasing, Procurement, and Label Control) are recognized and communicated throughout the transfer process.
  • Continuously enhance Technology Transfer standard operating procedures to streamline the transfer process. Proactively seek, develop, and implement innovative methods to simplify team operations.
  • Lead and execute Validation protocols in accordance with Good Manufacturing Practices (GMP) and standards for transferred products. Collaborate with the site Validations team to define and refine Validation standard operating procedures for consistency across the organization.
  • Exhibit advanced project management techniques to plan, monitor, and ensure the timely completion of transfer initiatives.
  • Leverage expertise in site manufacturing processes to promote, train, and enhance GMP adherence at the site, ensuring successful transfer activities from cost, quality, and delivery perspectives.
  • Integrate manufacturing requirements into development projects to ensure effective technical transfer into operations by providing input during the design phase for manufacturability considerations.
  • Engage in and/or lead cross-functional teams to ensure the objectives of the technology transfer project are achieved. Foster partnerships across various organizational groups (Lifecycle, Regulatory, and other business partners) as necessary.
  • Identify and resolve issues. Participate in transfer planning and process enhancements. Prepare and present project outcomes to diverse audiences.
  • Guide, mentor, and lead other Technical Transfer Specialists in project execution, providing direct oversight and direction on operational practices.
  • Demonstrate the capability to manage complex, multinational projects and navigate intricate technical, regulatory, and business landscapes. May receive special assignments requiring extensive global coordination.
  • Exhibit the ability to work independently with minimal supervision.
  • Perform additional duties as assigned by management.
Qualifications:
To excel in this role, candidates must effectively fulfill each responsibility. The qualifications listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform these responsibilities.

Education and Experience:
  • Bachelor's Degree in Engineering/Engineering Technology or Life Sciences with 5-8 years of relevant experience.
  • Master's Degree in Engineering/Engineering Technology or Life Sciences with 3-5 years of relevant experience.
  • PhD in Engineering/Engineering Technology or Life Sciences with 1-3 years of relevant experience.

Knowledge, Skills, and Abilities:
  • Exhibit potential for technical expertise, scientific innovation, collaboration, and independent thinking.
  • Possess a strong understanding of assay, bulk, and reagent manufacturing processes and design, with the ability to apply scientific methods in production.
  • Demonstrate advanced technical writing skills for report and document creation.
  • Ability to apply Six Sigma and Lean Manufacturing principles during the development phase.
  • Familiarity with systems such as SAP and ETQ is preferred.
EEO Statement: Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

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