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Tech Transfer Engineer

Job in St. Louis, Saint Louis, St. Louis city, Missouri, 63105, USA
Listing for: Harba Solutions Inc.
Full Time position
Listed on 2025-11-27
Job specializations:
  • Engineering
    Process Engineer, Manufacturing Engineer, Quality Engineering, Validation Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Location: St. Louis

We’re seeking a skilled and driven Tech Transfer Engineer to be a key force in transferring innovative drug products from development to full-scale manufacturing. In this high-impact role, you'll serve as a subject matter expert in process development, scale-up, and optimization while collaborating with cross-functional teams and external partners.

Responsibilities
  • Act as the subject matter expert for manufacturing processes and technical transfer of new products, with a focus on process development.
  • Independently plan, execute, and manage studies related to process development, optimization, scale-up, and preparation for manufacturing and technology transfer.
  • Represent the technical transfer function in meetings and conference calls with internal teams and external partners.
  • Develop production documentation and protocols to support qualification activities, technical transfer projects, and clinical or commercial manufacturing.
  • Train managers and production or laboratory staff on new processes and protocol requirements.
  • Present complex technical information clearly to support cross-functional decision making.
  • Write and update standard operating procedures, master plans, and other documentation in alignment with cGMP and cGDP requirements.
Qualifications
  • Bachelor’s degree in science or engineering, with a minimum of 12 years of relevant experience.
  • Strong knowledge of process design and development principles.
  • Experience in drug product manufacturing, including process development, scale-up, and optimization.
  • Ability to work under tight timelines and make sound decisions under pressure.
  • Proficient in data evaluation, statistical analysis, and process control.
  • Familiarity with sterile manufacturing principles, including aseptic or isolator-based systems.
  • Regulatory experience in pharmaceutical development or research is preferred.
Featured benefits
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
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