External Manufacturing Small Molecule API

Adecco Italia is looking for a Chemical Technician with esxperience in drug manufacturing (small molecule API).Our Small Molecule API Chemical Technical Operations Unit is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in API manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.This position reports to the Director, Chemical Technical Operations, External Manufacturing API Technology. The Technical Lead will be responsible for the management of the technical interface between the pharma company and External Partners (EP). The technical lead will provide process support to External Partners for existing supply products to resolve production issues, evaluate and manage process change requests, proactively assess, and manage process/technical risks, and provide guidance on process improvement and capacity optimization. The technical lead will also provide oversight of External Partners during New Product Introductions and Technical Transfers, proactively identifying process/technical risks as part of pre-execution activities, providing on-site support during execution, and supporting post-execution activities. Education Minimum Requirement: Bachelor's degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Science or other related science or engineering fieldRequired Experience and Skills: Experience in API chemical manufacturing in an API manufacturing facility. Knowledge of GMPs in API manufacturing. A Minimum of 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations or Technical Operations Experience in Quality Risk Assessments, deviation management and change control. Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation Experience in Tech Transfers Ability to work independently as well as excellent organizational skills. Strong professional and interpersonal communication skills Responsabilita: Responsibilities include: Work with external partners to achieve business goals and to establish a common culture that benefits our company, external partners, and patients. Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers. Responsible for technical transfer activities, as applicable, through review of GMP documentation (eg: Master Batch Records, change control, protocols, reports, qualifications, etc.) Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events. Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products. Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory Responsible for participation in creating, sharing, and adopting best practices and business process strategiesDuty Station: Montecchio Maggiore (Vicenza) We offer a 12-months fixed term contract. Annual Salary will be defined. Titolo di studio: Laurea Magistrale - Chimico / Biologico / Ambientale - Chimica e tecnologia farmaceutiche Lingue conosciute: Inglese: Comprensione Ottimo Competenze: Produzione - Supervisione macchine / ciclo produttivo, livello Ottimo Fogli di calcolo / elettronici - Excel, livello Ottimo Altro - Documentazione Conforme a Gmp, livello Ottimo Disponibilita oraria: Full Time CCNL: Chimica - Farmaceutica Industria