Drug Product Tech Transfer Support Lead (Biologics)

About the role

Global Manufacturing, Science & Technology (MSAT) is recruiting a Technical Launch Integrator Supporter (Senior Scientist) for its Biotherapeutics Drug Product Launch & Grow (Bio DP L&G) team in Schaffhausen, Switzerland. The Technical Launch Integrator (TLI) ensures site readiness for new product introductions moved from development to commercial sites and owns secondary tech transfers internally or externally. This role supports the TLI so that biologics launches and site-to-site transfers run smoothly.

Key responsibilities

• Integrate new and re-developed drug products from R&D into the supply chain, keeping the Best Process/Product at Launch (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).
• Act as the single point of contact for manufacturing site readiness between Development and Commercial supply chain.
• Identify ways to lower cost of goods and improve process robustness, fit for plant and commercialization.
• 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 NPI process, use technology platforms and speed up development timelines.

Required profile

• Bachelor's degree or equivalent (required); M.S. or PhD preferred.
• At least 4 years of experience in pharmaceutical product R&D and/or manufacturing, or equivalent (required).
• Experience transferring biopharmaceutical products to manufacturing sites, including knowledge of drug product unit operations (required).
• Knowledge of manufacturing site systems and GMP requirements (required).
• Proficiency in English (required).
• Willingness to travel domestically and internationally up to 20% depending on projects (required).

Required skills

• Document management systems such as RIMdocs, TruVault, SAP, MS Office, Comet and/or Planisware (preferred)
• Project management certification such as FPX or PMP (preferred)
• Knowledge of late-stage drug product development (preferred)

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