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Tech Transfer Expert; SME for Product Transfer Activities

  • Location:

    Ballerup Municipality, Denmark

  • Contact:

    Dave Twomey

  • Job type:

    Contract

  • Contact phone:

    +353 21 4857 284

  • Industry:

    Medical Device & Diagnostics

  • Contact email:

    dave_twomey@oxfordcorp.com

Our Danish client is seeking a Tech Transfer Expert to join a team of Subject Matter Experts (SMEs) supporting the transfer of commercial-stage products to vendors/CMOs across Europe, China, and the US. This position is part of a new SME team based in Denmark, focusing on product transfer, troubleshooting, and ensuring the technical success of these activities.

Key Responsibilities:

  • Act as the technical SME for technology transfer activities during the transfer of products to external vendors/CMOs.
  • Leverage a strong background in design or tech transfer within either the Medical Device or Pharmaceutical industries, ensuring seamless transition of combination products.
  • Support CMOs in meeting GMP standards and ensure a smooth transfer process, addressing challenges and troubleshooting in real time.
  • Take ownership of technical content, such as specification packages, drawings, procedures, protocols, and processes, and act as the first point of communication for CMO sites.
  • Provide technical guidance to CMOs, ensuring their readiness for product transfers and addressing complex technical questions.
  • Collaborate closely with CMOs, internal teams, and stakeholders to ensure successful outcomes.
  • Leverage internal SME networks for escalation and support when necessary.

Requirements:

Experience:
10+ years of hands-on experience in technology transfer activities at a mid-senior level. Demonstrable experience in executing similar transfer activities within the last 2-4 years, ensuring familiarity with the latest technologies and regulatory requirements
Technical Expertise:
Strong background in design or tech transfer within Medical Devices, Pharmaceuticals, or ideally both.
Combination product experience is highly desirable.
Industry Knowledge:
In-depth understanding of GMP standards and relevant regulatory frameworks.
Communication:
Excellent English language skills, both written and verbal.
Vendor Knowledge:
Prior experience with the client's vendors is a strong plus (specific vendors to be disclosed upon confirmation).

Additional Information:

  • The position will involve working closely with international CMOs, some of which may not currently meet GMP standards.
  • This is a contractor role requiring on-site work in Denmark, with collaboration across global stakeholders.
  • Candidates must demonstrate a proactive and problem-solving mindset to handle the complexities of the transfer process.

Location: Denmark
Contract Type: Contractor
Start Date: Immediate availability preferred

If you're an assembly expert with the technical expertise and experience to lead high-complexity product transfers in a regulated environment, we encourage you to apply!