Job Summary:
An exciting position for someone who would like to contribute to the successful development of a spin-off from the University of Liege. Aquilon Pharmaceuticals SA is a company that develops drugs for the treatment of pulmonary diseases through an innovative technology. This position is a key role for the successful pharmaceutical (CM&C) development of innovative inhalation products (drug-device combinations). You will have an active participation in the achievement of the Company’s objectives.

Key responsibilities:
• Work closely with key functions, especially within R&D department, to ensure that Aquilon’s project teams have enough information to make appropriate decisions on program milestones and next steps
• In collaboration with the COO and the R&D team, ensure smooth coordination of pharmaceutical and (bio)analytical activities in line with the preclinical and clinical studies
• Ensure consistency and regulatory compliance of pharmaceutical and (bio)analytical aspects throughout the development
• Ensure proper oversight of medical device development to meet the regulatory requirements linked to drug-device combinations

Tasks:
• Coordination and global oversight of the pharmaceutical and (bio)analytical development program of the drugs included in Aquilon’s pipeline, including third parties selection, from laboratory development up to clinical (and commercial) batches
• Oversight of Device Development to ensure matching of the drug and device properties according to Aquilon’s defined specifications
• Write and review pharmaceutical and (bio)analytical supportive information for the needs of R&D Department, Strategic Committee, Scientific Advisory Board and Executive Committee
• Planning, timelines compliance and prioritization of the pharmaceutical and (bio)analytical activities
• Budget set-up and follow-up for the pharmaceutical program
• Write and review pharmaceutical development plans and project updates, protocols and reports, including for grant applications
• Ensure proper documentation of the pharmaceutical, (bio)analytical and medical device development to meet the corresponding regulatory and GMP/GLP requirements, including regulatory documentation as needed for target product profile, regulatory briefing packages and clinical trial submissions
• Participate in risk management activities
• Participate in intellectual property strategy
• Participate in team meetings
• Organize CMC meetings and ensure their documentation (minutes, etc.)

Desired skills and experience:
• Scientific qualification (MSc or PhD in Chemistry or PharmD), expertise in inhalation products is a strong asset, Industrial Pharmacist/Qualified Person is an asset ;
• At least 5 years professional experience in a similar domain and/or position in the pharmaceutical or biotechnology industry;
• Fluent in English and French (written and oral), any other language is an asset;
• Knowledge of the applicable standards: GxP (in particular GMP and GLP), ICH guidelines (in particular related to the quality (Q) aspects), and of the EU and US regulatory requirements and documentation (IMPD, IND, CTD, etc.); knowledge of medical device standards and regulations is a strong asset
• Good understanding of the different drug development aspects related to the function: Chemistry, Manufacturing and Control (CMC), Quality, Regulatory, Bioanalysis, Non-Clinical studies (basics), Clinical studies (basics), etc. ;
• Ability to summarize the critical data and strong analytical thinking;
• Excellent communication skills;
• Excellent organization skills
• Ability to define and deal with priorities;
• Ability to work independently as well as in multidisciplinary teams;
• Adaptability and ability to quickly learn and implement new information, standards, regulations, tools, methods or software as it relates to the function;
• Experience in project management and team coordination;
• Good knowledge of standard MS-Office products.

To apply, please send an application letter and CV in English to [email protected].

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