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Scientific Manager Senior – New Chemical Entities (NCE) - Nanomedicines products (H/F/X)

July 22nd 2021

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

Mission Description

You will report to the R&D Director.
 
In this role you will promote the continuity and development of Quality Assistance’s activities within the biopharma market
 
This implies:
Ensuring regulatory watch for New Chemical Entities (NCE)/Nanomedicines products
o Attending scientific and regulatory meetings, conferences, webinars, …
o Keeping informed of upcoming regulatory texts, and transcribing the regulatory requirements into Quality Assistance procedures
o Gathering technical and scientific information obtained internally (Scientific Operations, Sales) and externally (customers, newsletters, bibliography, conferences, webinars).
 
Monitoring the progress of R&D projects related to New Chemical Entities (NCE)/Nanomedicines projects and supporting the R&D Director and the R&D Technical Leaders in method development, troubleshooting, and bibliographical search.
Ensuring that the communication material is always up-to-date as regards to new equipment, R&D projects, new regulatory guidelines, etc.
Upon request, supporting the Scientific Operations Department (SO) in terms of:
o Support for method development, data interpretation, troubleshooting, bibliographic searches. 
o Support and advise on the preparation of development, transfer and validation protocols. 
o Scientific review of reports and participation in technical meetings with customers.
Mapping, developing, and maintaining a strong network with external stakeholders and understanding their needs 
o Representing Quality Assistance at international conferences 
o Supporting Sales team 
Being the primary advisor for the sales team in taking part in technical and business discussions with the customers. 
Being the main contact point between the sales team and operations team. 
Targeting and soliciting internal experts in order to provide a response adapted to the client's needs
o Discussing with suppliers to clearly define Quality Assistance needs and meet the client’s needs
o Attending the meetings of internal groups of experts focused on the key analytical techniques used for the product
Working closely with Knowledge Management team to identify training needs to maintain and build up technical, scientific and regulatory expertise of QA staff members
o Providing training on the product, techniques. 
o Writing and updating training documentation on the product.
Supporting Technics Department 
o Being involved in the investment of new equipment dedicated to the analysis of the product. 
o Helping in the preparation of URS and DQ for new equipment. 

Candidate profile

Scientific background (PhD or Master / Engineer)
Required
Excellent knowledge of drug development workflows and of all the general pharmaceutical guidelines.
Experience in literature review and analysis.
Excellent oral and written communication skills.
Excellent knowledge of key aspects of New Chemical Entities (NCE)/Nanomedicines products (production, pharmaceutical development, mode of action). 
Excellent knowledge of all product-specific guidelines. 
Analytical expertise
o Excellent knowledge of all the analytical techniques required for the characterisation and analysis of the product. 
o Hands-on experience on part of key analytical techniques used for the product.

Offer

We are a true career partner.
We accelerate people’s access to new medicines.
We offer an inspiring work-life balance in a human scale environment.
We care about mutual respect, assistance and communication.
We listen to your needs and your suggestions.
We offer a market-competitive and package including numerous fringe benefits.

Contact Details

Send your application now (JOB279) to Mrs Isabelle Lebrun, Talent Acquisition Manager, to recrutement@quality-assistance.be or consult the Careers page on our website http://www.quality-assistance.com/careers/jobs.

Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium