Global biotechnology company
- Develop/establish process technology with maximizing manufacturing efficacy and cost efficiency in scale-up in terms of:
- Manufacturing Process in our formulation recipe
- Lead scale-up trial at the tolling site
- Packaging development and ensrue compatibility with formulations
- Take a part in manufacturing site decision from technical view points
- Specification control incl. change management
- Manage toll formulation/toller in terms of technical aspects and ensure safety in production.
- Monitor vendor capabilities and performance from technical viewpoints to optimize tollers' performance incl. BOM (Bill of Materials) performance.
- Provide improvement guidance to tollers and monitor them where improvements are needed. Reflect their performance to site decisions.
- Ensure QOTIF targets are met through effective collaboration with internal and external partners.
- Be proactive in the organization network to ensure the tactical application of the strategic policies and regional/territory collaboration for best practice implementation.
- Define requirements to contractually secure adequate capacity and competitive cost with the support of the Procurement business partner.
- Contribute to formulate risk management plan(s) in Supply Operations and support necessary audit for HSE and Quality manager. Set improvement plan with Toller in line with audit report and monitor progress.
- Understanding of production process, formulation & analysis technology, GMP, GLP, ISO and PL law.
- Understanding of IT especially database for information storing and retrieving.
- Technical communication with over sea people in English both writing and speaking.
- Task prioritization through technical implications and business impact
- On time and Precise communications and reporting backed up by fact-based analysis
- Minimum 2-3 year experience and project involvement in successful implementation of process technology and packaging of commercial product introduction.
- Involvement as team member in successful experience in introduction of GLP (or GMP or ISO).
Critical Technical, Professional and personal capabilities:
- Communication and collaboration skill not only within P&S organization but also other department or third party (Toller)
- License or educational background to be Poisonous and Deleterious Substance Management officer
Critical Success Factors and Key Challenges:
- Monitor vendor performance in the technical and quality area including HSE activities and implement continuous improvement.
- Maintain the database for customer complaints/questions/requests for sales forces to use in their sales activities and take improvement activities from the list.
- Be actively involved in product phase-in process to establish an optimal production at the most competitive production sites (both in-house and third party vendor).
Education / Qualifications:
- Bachelor degree of Chemical, Chemical engineering or Pharmaceutical
Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
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