R&D CMC Manager

An international pharma manufacturing company Headquartered in Italy is expanding its portfolio through new products introduction and is currently looking for the:R&D CMC MANAGERMain ResponsibilitiesReporting to the R&D and Quality Head, he/se will:· Undertake the full responsibility for the CMC activities and for the development of products (planning, coordinating and supervising the activities of products developed by external CDMO and reporting their progress to the Management, other departments and partners), including Analytical Development· Work closely with key functions, especially within R&D department, to ensure that project teams have enough information to make appropriate decisions on program milestones and next steps· Ensure that external laboratories/ CDMO/CRO meets the timelines and manage delays, negotiate delivery time and cater efficient information flow between internal and external teams· Negotiate and establish planning for Project budgets, and assess appropriate project scopes· Ensure proper documentation of the pharmaceutical, (bio)analytical and finished dosage forms development to meet the corresponding regulatory and GMP/GLP requirements· Work closely with Regulatory office to support and provide the proper CMC documentation for the Drug product registration dossiers· Ensure Contract Development and Manufacturing Organization (CDMO) selection according to each product needs· Have a global oversight of pharmaceutical activities, including the work of third parties, and ensure proper documentation·  Have a global oversight of the analytical and bioanalytical method development aspects to support pharmaceutical development, as well as nonclinical and clinical development  

Profilo

Main Requirements· The successful candidate must have proven experience in CMC and formulation development.· Knowledge of injectables and Biological Complex Drugs is required.· The candidate must have good understanding of the product development process from the Drug substance -   to the Drug Product formulation - to registered batches manufacturing, and the regulatory requirements allowing successful registration with the authorities. Given that most of the new developments are targeted for the EU&USA, experience with EMA&FDA requirements is a must.·  Strong educational background (Chemistry, CTF, Biotechnology…)· At least 8 years’ experience in the pharmaceutical industry, ideally in R&D CMC department· Proven track record in product management or equivalent with knowledge of product management techniques and tools.·  Ability to understand and analyse scientific data and results, and review scientific documents including drug development reports, publications, clinical documents and regulatory submissions· Strategic thinking, strong problem-solving and analytical skills· Understanding the scientific principles and regulatory requirements· Strong sense of planning and prioritization· Fluent in English, both written and oralPlace of work: the position can be equally based in one of the Sites in Emilia Romagna or in LazioThe research is aimed at people of both sexes (Law 903/77). Potential candidates could send a curriculum vitae with the authorization to process personal data (article 13 GDPR 679/16) to the e-mail address site@proman.bz