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Johnson & Johnson > offerta di lavoro n. 236865

immagine: lavoro con Johnson & Johnson

Technician Qc Npi

> 2005826554W

contratto
Assunzione alle dipendenze

durata
Tempo indeterminato

regime orario
Full time

luogo di lavoro
IT Lazio, Latina

area professionale
Ingegneria, Progettazione, Qualità

livello professionale
Quadro, Manager,Senior

offerta non piu attiva

Descrizione della posizione

The Technical Launch Integrator (TLI) has overall 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. A main objective of the role is strong collaboration with R&D and the commercial manufacturing site to ensure a robust product and manufacturing process is developed and successfully transferred.

Areas of responsibility include Drug Product (DP) technical support and oversight for the supply chain, planning and execution of DP manufacturing site level support of new product launch activities. The TLI is a member of manufacturing site operational teams, CMC DPD Sub team, and JSC Value Chain Team, and leads the new production introduction team at the DP manufacturing site.

This position is focused on DP with the responsibilities potentially growing to coordination of Active Pharmaceutical Ingredient (API) activities allowing a full End to End perspective to the TLI function.


Key Responsibilities:

  • Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support of new and re-developed drug products from R&D into the supply chain.
  • Routine technical support during execution of transfer activities, including integration of JSC technical expertise and QbD principles into project execution at the commercial manufacturing site level.
  • Contribution, review, and approval of drug product technical and regulatory documents for global markets.
  • Leading the DP manufacturing site team and manufacturing site representative on the CMC DPD Sub-team and the Value Chain Team.
  • Identifying and implementing opportunities for active decrease in DP COGs and partnering with DPDS and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain.
  • Partnering with the DP SI to provide all DP manufacturing site related needs to the DPD Sub-team as the single point of contact at the site.
  • Developing the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the CMC DPD Sub-team and JSC Value Chain Team. The TLI will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function of JSC Technical Operations.
  • Providing required manufacturing site based technical support, technical documentation input, review and approval and serving as the JSC technical product expert.
  • Coordinating and executing product introduction at the site from DP transfer through launch covering raw materials, formula, process, packaging and device integration into the finished DP, and supporting the VCL for site related launch activities.
  • Delivering clinical through commercial DP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.
  • Overall focus will be on DP, however, willingness to learn and coordinate API activities is expected.
     


Qualifications

Education:

Degree in Scientific or Engineering field such as Chemistry, Pharmaceutics, Chemical Engineering. Minimum requirements: BS/BA with 9 years of relevant work experience, M.S. with 7 years of relevant work experience or PhD with up to 3 years of relevant work experience in pharmaceutical development or pharmaceutical manufacturing.

Experience and Skills Required:

  • Broad and proven technical background in pharmaceutical product manufacturing, process & product development, quality, cGMP and regulatory knowledge related to solid oral dose products.
  • Demonstrates strong interpersonal skills and effectively communicates across all levels (shop floor to management stakeholders), with ability to thrive in a matrix environment – leading without direct line authority.
  • High level of maturity to lead moderate to large, complex projects and teams, programs or initiatives, both internally and externally.
  • High level of autonomy, able to self-direct, plan and execute.
  • Strong risk assessment / risk management skills with ability to balance considerations toward business, scientific, quality, EHS, and compliance needs.
  • Knowledge of plant functionality, plant capacity and COG calculations
  • Eye for business: negotiation and sourcing strategies and financial impact (finance for non-financial professionals)
  • Decision making and problem-solving: able to tackle complex or unusual problems independently or through others, and develops recommendations or design solutions.
  • Investigation handling and statistical assessments supporting CPV deliverable's (ensuring a robust process).


Preferred:

  • International experience and interest in collaborating with various cultures / nationalities / perspectives.
  • Partial experience in Active Pharmaceutical Ingredients.
  • Knowledge of contract manufacturing activities and crafting working relationships with external partners and global cultures.
  • Influences others with shared or different interests often beyond scope and level, networking, convincing for priority setting, both internally and externally to the company.


Other:

  • Proficient in written and spoken English and Italian languages
  • Works in an international environment with flexibility to allow collaboration across different time zones. Project management Certifications preferred. Eligible to work in Italy.

 

Specific systems:

  • Document mgmt. systems such as TruVault, SAP, MS Office applications, TrackWise, Minitab or similar statistical software


Physical requirements/working conditions:

  • Travel: Travel up to 25% - project dependent

Avvertenze

La presente inserzione è pubblicata allo scopo esclusivo di raccogliere candidature in relazione ad opportunità di lavoro o formazione effettivamente esistenti presso la nostra azienda o presso società controllate o partecipate. È pertanto esclusa qualsiasi finalità di intermediazione. La ricerca è rivolta a candidati di entrambi i sessi (L.903/77). I dati saranno trattati ai sensi del Regolamento UE 2016/679.

offerta non piu attiva