Γραφείο Διασύνδεσης & Σταδιοδρομίας

AbbVie

Provide technical support for the manufacturing of commercial products and products in late stage development.
Liaison between various functional groups, as well as, Third Party Manufacturers .
Responsible for reviewing and approving deviations, change requests, non-conforming material reports and investigations in terms of the technical content.
Write/co-author/review/approve process validation documents and scientific reports in support of both validation activities and Regulatory submissions. Provide supportive quality control and manufacturing documents to Regulatory requests including field alerts/actions.
Identify and resolve manufacturing issues for commercial and Development products.
Provides technical leadership to cross-functional teams during development, commercial launch or trouble shooting of established processes.
Participation in continuous improvement projects and in global initiatives. Present results of projects and issues to senior management.
Organization and prioritization of projects activities to meet given timelines/milestones.

Engineer/Master/Diploma, PhD preferred, in Pharmaceutical Sciences, Chemistry, Chemical Engineering or similar field
Experienced with the preformulation, formulation development, process development and manufacturing of solid dosage forms
Experienced with working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements and standards
Excellent team working and communication skills
Able to identify, describe and resolve technical problems using systematic and scientifically sound first principle approaches
First principles understanding of analytical methods for the characterization of material properties of excipients, API’s and formulations
Excellent knowledge of advanced statistics and probability methods as applied in drug development
Fluent in spoken and written English
Experience with continuous improvement programs e.g. Lean Six Sigma is beneficial