Technology Transfer Specialist

6 giorni fa

Milano, Italia Recordati A tempo pieno

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve.
We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple.
We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege.
Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop.
Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati.
Unlocking the full potential of life. Job PurposeWe are seeking a highly motivated Technology Transfer Specialist to coordinate and support the process transfer activities between sending and receiving sites which can be either internal or external (CDMO) to the organization.
The position requires good knowledge of most primary pharmaceutical manufacturing processes (oral, semisolid, liquid and sterile dosage forms).
Additionally, pro-active cooperation and clear communication with colleagues at Recordati and the external partner is essential.
Key ResponsibilitiesProject managing the technology transfer and related activities of drug products, drug substances and analytical methods ensuring the successful delivery in terms of quality, costs and time.Handling and reviewing initial quotes, defining technology transfer costs and monitoring of the approved budget.Working closely with key functions (procurement, finance, supply chain, regulatory, quality) to define transfer strategy and develop business cases.Collecting information from different sources and incorporating into activity reports and action plans.Communicating on project or transfer status, decisions, prioritizations, and delivering presentations to internal stakeholders and external partners.Acting as a focal point in defining the project scope and preparation of the technology transfer plans, setting project deliverables and associated timelines.Supporting the process of identifying, analyzing and responding to any risk that arises over the life cycle of the technology transfer.Generating / reviewing technology transfer documentation such as Request for Proposal, Technology Transfer Plan/Scope, Project Timeline, Technical / GAP assessment, Technology Transfer Report.Reviewing relevant technical documents associated with technology transfer (process validation protocols/reports, manufacturing batch records, analytical protocols/reports).Required EducationDegree educated to BSc or higher within a scientific discipline (Chemistry, Pharmacy, Pharmaceutical Sciences, Biology, Industrial engineering).
Required Skills and ExperiencePrevious work experience in Pharma Industries.Analytical abilities with detail orientation.Knowledge of GMP pharmaceutical processes and scale-up and guidelines/regulations.5/6 years of experience in the project management of technology transfers.Hands-on experience in writing, reviewing and approving process, analytical protocols, reports and regulatory justifications for variations or submissions related to these subjects.Proven computer proficiency with Microsoft Office programs and database management skills.Required Behaviours and CompetenciesProactively identify areas for improvement in the execution of procedures.Communicate risks to timelines in a proactive manner.Travel required in %20-30%
At Recordati we believe in people
Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion.
We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer.
We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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