Chercheur Formulation (F/H/X)

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor²) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com

As a Formulation Scientist, you will be responsible for drug product formulation development projects for new chemical entities (small molecules) in support of (pre)clinical, non-clinical and stability studies as well as supporting (bio)analytical development by providing formulations to the analytical platform. You will be expected to provide technical expertise and scientific input on formulation development strategies, in order to enable early preclinical studies as well as future-proofing the formulations for later stages of development. Formulations to be developed can be aqueous/lipidic solutions, suspensions or other innovative presentations and are intended for the oral and/or the injectable route. You will work closely with laboratory technicians and align with the project management team.

MISSIONS:

Your responsibilities include, but are not limited to:

Prepare formulation development projects (literature review, experiment design including potential DoE approach), execute and report (data analysis);
Draft work instructions for laboratory technicians to ensure that work is performed efficiently and in a scientifically sound manner;
Streamline the activities associated with a wide variety of formulation technologies to shorten Formulation Lab turnaround times and improve the quality of formulations being delivered;
Monitor experiments (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way;
Write scientific reports e.g. formulation development reports;
Help identifying potential stability and performance issues with prototype formulations;
Take part in process optimization studies, internally or via an external supplier, and transfer the developed process to the CMC team in preparation of clinical studies;
Support the scale-up of developed formulations and bring them to GMP manufacturing;
Provide scientific expertise and formulation insights to Core Teams meetings.

PROFILE:

You hold a PhD with 3+ years of drug product formulation experience or a master’s degree in Life Sciences and 5+ years of drug product formulation experience in the biopharmaceutical industry, academia, or a related environment;
You have demonstrated expertise in formulation development and process optimization in an early-stage/preclinical development setting;
You have previous experience in (pre)clinical, non-clinical stage development phases;
You have experience working on aqueous/lipidic formulations and/or other innovative presentations for the oral and/or injectable routes;
You possess deep knowledge of relevant techniques and regulations required for formulation development, with a focus on creating processes that are scalable for later stages;
You possess excellent verbal and written communication skills with the ability to effectively engage various stakeholders;
You are able to critically evaluate scientific literature to help prepare formulation development projects;
You are fluent in both French and English (B2+ level required for both).

With respect to recruitment, GENFIT commits to providing equal treatment to all applicants, regardless of gender, age, sexual orientation, ethnicity, race, citizenship, disability status, religion, or any other discriminatory characteristic under applicable laws. By choosing to apply for a position at GENFIT, you agree that fostering an inclusive and diverse work environment is our shared responsibility.