Senior Scientist responsible for technical contribution to transfer, maintain and optimise supply for AstraZeneca commercial products, including process improvements, laboratory experimentation, in-silico modelling and manufacturing support.
Responsibilities
Support technical contribution to transfer, maintain and optimise supply for one or more AstraZeneca commercial products
Identify, develop and implement process improvements for both launch and commercial products
Provide expert technical input through laboratory experimentation, in-silico modelling and direct manufacturing support at the internal AZ API manufacturing site in Dublin
Contribute to the CMC components of regulatory submissions and preparation of successful query responses over the commercial life of a product
Requirements
BSc/PhD level education in a relevant discipline
Nice to have: Experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process development
Nice to have: Experience working within a Research & Development and Manufacturing environment in the pharmaceutical industry
Nice to have: Experience of technical supervision and leading small teams of people or scientific projects
Nice to have: Experience of late stage development or commercial supply with a background in a process chemistry skill group
Pharmacien titulaire d’une thèse d’exercice, avec un troisième cycle juridique ou réglementaire, chargé de la gestion réglementaire et qualité des produits cardiovasculaires, rénaux et métaboliques.
Responsibilities
Préparer et soumettre les dossiers d’enregistrement, de variations et de renouvellement (procédures nationales et européennes)
Assurer la mise à jour des bases de données
Être l’interlocuteur privilégié des autorités de santé
Piloter la mise à jour des articles de conditionnement
Rédiger les mentions légales et mettre à jour les monographies VIDAL
Base hourly pay of $21.00 per hour
Hours (Monday-Friday, 6:00 AM-2:30 PM EST)
Responsibilities
Handle raw materials, transport from storage to dispensary, weigh them as required, per the batch formula and add them to required mixer.
Load blenders, complete final packaging, and sample per batch requirement, inspect both raw materials and finished goods as well as safely palletize and store raw materials and/or finished goods.
Monitor, report, and document equipment failures; record exception, deviations and actions taken.
Report disturbances to the Supervisor or backup supervisor and inform him/her about production process adjustments/concerns.
Take samples of raw materials and finished goods for quality and analytical testing.
Requirements
High School Diploma/GED
Nice to have: At least one-year prior manufacturing working experience
Assistant Production Operator helping produce safe, high-quality food ingredients by operating modern equipment in a GMP-regulated environment and monitoring processes.
Compensation
Hourly rate $19.00-$22.00
Responsibilities
Accurately maintain proper documentation of process information
Follow all safety guidelines and immediately report any non-conformances
Maintain GMP work environment and perform housekeeping duties as assigned
May operate computerized control systems to monitor and maintain process conditions
Add proper levels of chemicals and other additives to process as needed based on calculations or as determined determined
Lead the School of Government and Policy’s events function, from strategy to execution, managing complex, high-profile events and building the school’s public profile.
Senior Scientist (Chemistry)NewAstraZeneca · Dublin, Ireland