18 set - Teramo
Johnson & Johnson
Overview
In this MSAT-focused role, you drive technical oversight of external manufacturing sites for Synthetics Drug Product, guiding NPI, tech transfers, and product lifecycle management. You act as the primary technical voice for EM interactions, coordinating risk assessments, standards deployment, and site onboarding. You collaborate across MSAT teams to de-risk products and implement new technologies. You’ll shape manufacturing science and ensure compliance across global supply networks.
Retribuzione / Benefits
- annual premio
- vacation days
- parental leave
- bereavement leave
- caregiver leave
- well-being reimbursement
Responsabilità
- Execute drug product technology transfer and lifecycle activities, including material qualification and cleaning validation
- Support NPI using established tools and collaborate with VMT and EM sites
- Act as Technical coordinator for CMOs, defining technology standards and MSAT roadmaps
- Serve as primary site owner for EM technical issues and represent MSAT in cross-functional forums
- Maintain knowledge of ongoing and planned technical activities at the site
- Engage in Site Lifecycle processes (due diligence, onboarding, monitoring, disengagement) and support localization
- Support EM handling tools, including risk metrics and segmentation models, and assist account planning
- Perform technical assessment of change controls and support audits/inspections with Quality
Requisiti fondamentali
- Bachelor in Engineering or Pharmaceutical Science or equivalent (minimum)
- Minimum 8 years of relevant experience
- Experience with dosage forms and process science, tech transfer for liquid and solid manufacturing
- Experience with external manufacturing network (EM)
- Basic knowledge of Small Molecule supply chain
- Strong communication and teamwork skills
- Ability to lead activities under general direction and prioritize
- Strong knowledge of Quality & Compliance and GMP/EHSS regulatory requirements
- strong communication
- teamwork/networking
- prioritization
- dosage form experience (liquids, solids)
- process science
- tech transfer
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