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(Senior) Scientist Parenterals

il y a 1 mois

Gent, Belgique Ardena Temps plein

**About us**

**Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.

Ardena is a rapidly growing international orientated organization with a dedicated team of 700 professionals operating from 6 sites in Belgium, the Netherlands, Sweden, Spain and the United States. Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.

We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.

For the Ardena Business Unit **Drug Product Development and Manufacturing (DDM) **based in Ghent (Belgium), we are looking for a

**(SENIOR) SCIENTIST PARENTERALS & LIQUIDS**

**YOUR KEY ROLE**

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

As a (Senior) Scientist Parenterals & Liquids, you are the leading person from the Galenic Team responsible for parenteral drug product development projects of new chemical entities in support of (pre)clinical studies and stability studies. The (Senior) Scientist Parenterals & Liquids is expected to lead the project by independently prepare and execute the formulation development work, with a key focus on injectable formulations (for small and/or large molecules). To support daily activities, you will work closely with both manufacturing operations and engineering teams.

**YOUR KEY RESPONSIBILITIES**
- Provide technical/scientific expertise for parenteral product development: focus on designing studies related to (pre-)formulation, including solubility, pH stability, filterability and lyophilization while keeping GMP manufacturing in mind. Support investigations, CAPAs, change controls, and review critical raw data for key documents when needed.
- Support the upscaling and tech transfer activities from R&D to Aseptic GMP Manufacturing (Fill & Finish).
- Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key document.
- Prepare and Review, when required, relevant technical documents, such as: Batch Records, Changes, etc.
- Providing scientific expertise and formulation insights to Core Teams meetings
- Assisting to client meetings to present scientific data in a clear manner
- Supporting Business Development and Client Services on new and repeat business
- Writing scientific reports for clients, e.g. formulation development reports
- Drafting work instructions for the (Associate) Scientists to ensure that work is performed efficiently and in a scientifically sound manner
- Monitoring experiments (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way
- Identifying potential stability and performance issues with prototype formulations

Streamlining the activities associated with a wide variety of formulation technologies to shorten Formulation Lab turnaround times and improve the quality of formulations being delivered

**YOUR PROFILE LOOKS LIKE/RESEMBLES**
- PhD level education in the field of Pharmaceutical Sciences and specialised in injectable formulations or equivalent through experience
- Having a proven track-record for working on injectable formulations is mandatory (+5 years of experience)
- Expertise in working with proteins is a plus
- Background in sterile GMP is a plus
- Excellent oral (presentations) and written (reporting) skills in English
- Flexibility to work in both an R&D and GMP environment
- Self-motivated and able to adapt to changing environment with ease
- Work independently or as part of a team, able to stimulate other co-workers
- Able to deliver results within limited time and budget; solution-oriented

**WHAT WE OFFER**
- Opportunity to make impact on multiple projects with a variety in formulations and technologies
- Ability to further grow your formulation and project management skills while working within multidisciplinary teams
- A true learning environment where you will have the ability to grow your skills
- A rapidly International developing and growing company with an interesting services, product and custome