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Senior Scientist
3 months ago
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Responsibilities
Job Overview:
We have an immediate opening for a Senior Scientist with experience in the pharmaceutics / biopharmaceutics area to work primarily on oral absorption PBPK modelling (less or more qualified candidates may be considered at different levels). The candidate should have expertise at applying mathematical/scripting skills to build, for example, mechanistic models of drug product disintegration or drug release/dissolution or appropriate transferable skills to work in this domain. Experience of developing formulations and of in vitro experimental methods used during formulation development in a commercial environment is an advantage. The successful candidate will assist with the development of physiologically based pharmacokinetic (PBPK) models focused on algorithms related to simulating drug product absorption and bioavailability within the Simcyp Simulator and Biopharmaceutics. Experience in pharmacokinetics, drug product bioequivalence analysis, and hands-on use of PBPK software are all advantageous but not essential. However, an understanding of the impact of critical quality attributes in drug product development is important.
In addition to model development, specification, and testing, the post holder is eventually expected to provide on-going customer support, education, and training related to the use of the Simcyp PBPK Simulator, and to act as tutor at Simcyp workshops. The post does not include laboratory or clinical work. We offer a unique and exciting mix of academic and commercial environments which encourage regular attendance at scientific meetings as part of continuous education programs and publication in peer reviewed journals. The projects are scientifically challenging yet focused on solving practical issues relevant to modern drug development and hence collaborative work with pharmaceutical companies is part of the activities. All scientists are expected to participate in writing scientific reports relevant to their work under the guidance of our world-leading senior scientists within the group.
Qualifications
Essential
PhD (or equivalent experience) in Pharmaceutics or a related area with transferable skills. Demonstrable ability to develop mathematical (mechanistic) models of complex processes such as, but not restricted to, dissolution/release from oral drug products. Working knowledge and understanding of drug delivery and the impact of critical quality attributes on product performance coupled with a willingness to expand knowledge in this area. Demonstrable communication skills, as evidenced by presentation at scientific meetings, peer reviewed publications, and good interpersonal and organizational skills.Desirable
Practical knowledge of in vitro experiments used to assess drug product release/dissolution. Working knowledge of PBPK models Use of PBPK modelling in industrial settings and regulatory interactions Awareness of R&D processes in pharmaceutical companiesCertara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
