R&D Manager

CordenPharma Caponago
Caponago, IT
Full-time

CordenPharma Caponago

Caponago, IT
Full-time

CordenPharma Caponago

CordenPharma Caponago é un sito produttivo di farmaci liquidi sterili ad uso iniettabile, con competenze specialistiche nella tecnologia delle emulsioni sterili e un’ampia gamma di capabilities che includono sviluppo della formulazione, produzione e confezionamento di farmaci per uso commerciale e per sperimentazione clinica e logistica farmaceutica.

Come precedente stabilimento di produzione Astrazeneca, il sito di Caponago apporta alla piattaforma CordenPharma’s full-service CDMO oltre 20 anni di esperienza con particolare attenzione nella tecnologia delle emulsioni sterili, coprendo tutte le fasi dalla preparazione dell’emulsione, al riempimento e la sterilizzazione terminale fino all’ ispezione, l’etichettatura e il confezionamento. Il sito é ispezionato dall’EMEA (AIFA), FDA, ANVISA, TGA e dall’Autorità Giapponese.

Lo stabilimento di CordenPharma Caponago applica tecnologie di riempimento sia a sterilizzazione terminale che in asepsi per siringhe preriempite, flaconi, fiale e flaconi liofilizzati con un’ampia gamma di volumi di riempimento.

 

For the new R&D department, we are looking for a qualified:

R&D Manager

Reporting directly to the Managing Director of CordenPharma Caponago, a plant dedicated to the contract development and manufacturing of injectable drugs in aseptic or terminal sterilization technology.

RESPONSIBILITIES:

  • >> Ensuring contract research and development activities for new injectable pharmaceutical products and for new formulations of those already consolidated as well as supporting technology transfer and clinical trial batches production activities
  • >> Responsible for the development of methods to release substances and new pharmaceutical products to be transferred as well as duly performance of analytical development activities and routine implementation
  • >> Collaborating with customers and project managers in the project planning and in the drafting of the related documents (ideally using the required DOE and QBD, analytical and validation techniques as well as the SHE function on the new substances introduction and the evaluation of PPE to be adopted during the manufacturing processes)
  • >> Managing the training of the production operators for the internal technology transfer from development to commercial manufacturing, taking also care of safety aspects
  • >> Responsible for the definition and the controlling of the budget for the department as well as properly carrying out the team leader function

SKILLS:

  • >> University degree in scientific subjects with experience in the pharmaceutical industry of at least 10 years. Experienced in R&D or pharmaceutical production; previous experience in the CRO and CDMO business preferred
  • >> Technical competences in the aseptic techniques on injectable and freeze-dried; previous experience in sterile emulsions a plus
  • >> Act as a strong leader and team player within an international matrix organization as well with the team at site, developing efficient and structured ways of working with all stakeholders, especially customers with regards to expectations
  • >> Able to deal with stressful situations and entrepreneurial behavior, striving for results through taking ownership, being demanding and persistent as well as being solution focused and achievement-orientated
  • >> Very good knowledge of MS- Office tools and excellent communication skills in Italian and English (both written and oral)

CANDIDATURE:

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