For one of my leading pharmaceutical clients I am urgently looking for a Drug Product Technical Owner / Technical Launch Integrator within the Technical Operations Large Molecule Global Team. Would you like to be part of our team to contribute to this groundbreaking development and bring life threatening diseases to a halt?
- Duration: 1 year initially
- The role is remote, the specialist will work on customer's device (laptop) and travel to the manufacturing site only if needed.
This position has accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place.
The TLI is a member of the manufacturing site operational teams, CMC DPD Sub team, and JSC New Product Team and leads the new production introduction team at the DP or DS site.
- Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large molecule).
- Leading the Drug Product manufacturing site team and manufacturing site representative on the Drug Product Development Sub team and the JSC New Product Team.
- Single point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site-based documentation, planning, risk management, budget) including launch support.
- JSC technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants.
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution and QbD technical implementation at the manufacturing site level.
- 7 years and BS degree; Or 4+ years and MS/MBA/PhD.
- Experience in Fill Finish, Manufacturing in a Drug product environment (better if large molecules)
- Strong project management skills with experience in supporting the execution of large-scale projects.
- Experience working with aseptic production (better in large molecules), this include the introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP.
- Knowledge in process validation, and aseptic process equipment requirements
- Hands-on experience and solving batch issues
- Ability to lead, encourage and coach project teams and individuals
- You are able to work with Health Authorities and technical representatives from Partners and Contract Manufacturers, and to provide answers to HA questions on regulatory documents, ensure technical PAI inspection readiness, etc.
- Lead multi-functional and third-party teams for complex investigations, Tech Transfer and process improvement projects.
- General knowledge of the pharmaceutical industry
- Knowledge of manufacturing site systems and procedures
- Proven ability to partner and work with multiple departments and manage projects. Experience with technical transfers involving cross-functional, cross-geography, and cross-company teams
- Demonstrated leadership in providing integration of activities and information across multi-functional groups and matrix teams.
- Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button below. For further information, please contact Daria Petrova at +31 (0)20 20 44 502 or by email at email@example.com