Drug Product Tech Transfer Lead (Biologics)

About the role

The Technical Launch Integrator (TLI), posted as Drug Product Tech Transfer Lead, is accountable for ensuring drug products are fit for plant and commercial readiness during technical development, including the implementation of new innovations and technologies. The role covers the transfer of pharmaceutical processes and products into the supply chain and the global marketplace, as well as site-to-site transfers, keeping the Best Process/Product at Launch (BPAL) mindset. It sits in Supply Chain Engineering, Process Engineering.

Key responsibilities

• Integrate new and re-developed drug products from R&D into the supply chain with new technologies, keeping the BPAL mindset.
• Contribute to, review and approve drug product technical and regulatory documents, give routine technical support, integrate supply chain expertise into projects and implement Quality by Design (QbD) at the manufacturing site.
• Act as single point of contact for plant readiness and launch support between Development and Commercial supply chain.
• Identify ways to reduce Cost of Goods (COGs) and improve process robustness and commercialization of new products.
• Develop the manufacturing site execution plan per product and coordinate product introduction from transfer through launch, covering raw materials, formula, process, packaging and device integration.
• Optimize the New Product Introduction (NPI) process, use technology platforms and accelerate development timelines.

Required profile

• Bachelor's degree or equivalent (required); M.S. or PhD preferred.
• Minimum 6 years of relevant experience in pharmaceutical product R&D and/or manufacturing / MSAT functions (required).
• Experience transferring biopharmaceutical products to manufacturing sites, including knowledge of DP unit operations (required).
• Knowledge of manufacturing site systems and GMP requirements (required).
• Knowledge of DP late-stage development preferred.
• Proficiency in English (required).
• Willingness to travel domestically and internationally up to 20% depending on project needs (required).

Required skills

• Document management systems such as RIMdocs, TruVault, SAP, MS Office, Comet and/or Planisware (preferred).
• FPX, PMP or equivalent project management certification (preferred).
• Preferred skills listed: CAPA, Lean Supply Chain Management, Process Engineering, Program Management, STEM.

Applicants should submit an updated CV and cover letter in English; the selection process starts during the posting period.