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 a tech transfer expert with the technical expertise and experience to lead the transfer of combination products in a regulated environment, we encourage you to apply!

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