Descripción de la oferta
Position: Pharmacometrician Scientist Location: Azuqueca de Henares. Experience: 2 to 4 years in similar roles. Do you want to know more? INSUD PHARMA operates throughout the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to both human and animal health. INSUD PHARMA’s activity is structured into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. Are you ready to be a #Challenger? What are we looking for? The challenge! Provide technical and scientific support for NME and complex generic development projects, driving appropriate biopharmaceutical assessment and contributing to the selection of formulation prototypes. Identify relationships between drug substance properties, dosage forms, drug release, and drug absorption. Build mathematical models describing formulation effects on drug absorption (IVIVC and PBPK models). Develop predictive PK models based on in vitro dissolution data (IVIVC). In collaboration with other team members, develop PK/PD models to address questions related to complex generic products. Contribute to the implementation of new tools and solutions to strengthen in vitro–in vivo relationships within the department. Author, review, and contribute to scientific documentation and technical reports to support regulatory submissions (including scientific advice packages and responses to deficiency letters). Interact and collaborate scientifically with internal cross-functional project teams and external partners. Maintain compliance with internal SOPs, regulatory guidelines (ICH, EMA, FDA), and GCP/GLP quality standards. What do you need? University degree in Pharmacy, Bioinformatics, Biopharmaceutics, or other related sciences. PhD in data modeling or related field is a plus. Strong background in pharmacokinetics and IVIVC. Knowledge of in vitro dissolution testing (biorelevant/biopredictive API and formulation testing). Hands-on experience with programming languages such as R or Python. Experience with pharmacometric and PBPK platforms such as Phoenix, NONMEM, Simcyp, GastroPlus, PK-Sim, or equivalent tools. High level of English (spoken and written). Intermediate level of Spanish. Our benefits! ⏰Flexible entry schedule from Monday to Friday (full-time, 40 hours). Permanent contract Attractive salary package.
