Manufacturing Transfer Specialist

1 week ago


Tucson, Arizona, United States R&D Partners Full time

A leading biotechnology firm is seeking a Technical Transfer Specialist to facilitate Operations, Development, and Regulatory functions during the introduction of new Assays, Reagents, and Bulk Materials. This role is pivotal in ensuring that all operational requirements are satisfied from perspectives of manufacturability, quality, cost, and scheduling.

Key Responsibilities

  • Communicate and implement manufacturing best practices to the core project team to guarantee manufacturability and scalability.
  • Ensure that the needs of all Operations stakeholders (including Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing, and Label Control) are recognized and conveyed throughout the transfer process.
  • Acquire and apply Technology Transfer standard practices to perpetually enhance the transfer process.
  • Utilize project management methodologies to plan, monitor, and ensure the timely execution of transfer projects.
  • Gradually develop expertise in site manufacturing processes to advocate, instruct, and enhance GMP at the site, ensuring successful transfer activities from cost, quality, and delivery perspectives.
  • Incorporate manufacturing requirements into development initiatives to ensure effective technical transfer into operations by providing input during the design phase for manufacturability.
  • Execute Validation protocols with support from fellow Technical Transfer Specialists, adhering to Good Manufacturing Practices (GMP) and standards for transferred products.
  • Engage in cross-functional teams to meet the objectives of the technology transfer project.
  • Diagnose and resolve issues as they arise.
  • Contribute to transfer planning and process revisions.
  • Prepare and present project results to various audiences, effectively communicating data.

Qualifications

  • Bachelor's Degree in Engineering/Engineering Technology or Life Science discipline with 1-3 years of relevant experience, or a Master's Degree in a similar field with 0-2 years of experience.
  • Exhibits potential for technical expertise, scientific innovation, collaboration, and independent thinking.
  • Basic understanding of assay, bulk, and reagent manufacturing processes and design, with the ability to apply scientific methods in production contexts.
  • Strong technical writing capabilities for generating reports and documentation.
  • Ability to implement Six Sigma and Lean Manufacturing methodologies during development phases.
  • Familiarity with systems such as SAP and ETQ.

Salary Range:

  • $53,248 - $66,560

Why Choose R&D Partners?

As an employee, you will benefit from a comprehensive benefits package, which includes:

  • Medical insurance options – PPO, HMO & HSA
  • Dental & Vision coverage
  • 401k retirement plan
  • Employee Assistance Program
  • Long-term disability coverage
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval system

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research, and engineering. We offer job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.



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