Oculis
Oculis
Oculis

Formulation Project Manager

In the context of the company growth, Oculis is currently looking for a Formulation Project Managerfor its Research Laboratory located in Reykjavik, Iceland. This laboratory is in charge of drug-product formulation and the Formulation Project Manager oversees the whole predevelopment process from early-stage project design up to the final lead formulation readiness for industrial scale-up.

Menntunar- og hæfniskröfur
Required skills and competencies:
Bachelor’s and/or post-graduate degree or equivalent in chemistry or pharmaceutical sciences, with at least 5 years of experience in either pharmaceutical or biotechnology industry.
Experience of formulation and manufacturing process development, ideally of sterile products.
Strong hands-on expertise in analytical method development, incl. HPLC.
An experience in drug registration dossier submission process in either USA or EU (CTD/Module 3) would be considered as a plus.
Thorough understanding of cGMP, pharmacopeia testing and regulatory requirements for drug development and approval.
Good knowledge of written and spoken English.
Good communication and teamwork skills.
Helstu verkefni og ábyrgð
Main Responsibilities:
Ophthalmic formulation design.
Design and perform experiments for drug pre-formulation, formulation, and process definition.
Analytical method development.
Product manufacturing process definition.
Auglýsing birt26. maí 2021
Umsóknarfrestur15. júní 2021
Tungumálahæfni
EnskaEnska
Nauðsyn
Meðalhæfni
Staðsetning
Álfheimar 74, 104 Reykjavík
Starfstegund
Hæfni
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