Senior Scientist, Biopharmaceutics Modelling & Simulation
2 days ago
Stone Cross
Senior Scientist, Biopharmaceutics Modelling & Simulation (PBBM/PBPK) 12 months Sandwich, UK 37 hours p/w We are seeking a highly motivated Senior Scientist with expertise in Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modelling (PBBM) to support the development and optimization of innovative drug products across all stages of development. The successful candidate will apply mechanistic modelling and simulation approaches to understand and predict the impact of drug substance properties, formulation design, dissolution, physiology, and clinical variables on in vivo performance and patient outcomes. The scientist will work within multidisciplinary project teams and collaborate closely with scientists in biopharmaceutics, formulation development, clinical pharmacology and PDM (Pharmacokinetics, Distribution and Metabolism) to support model-informed drug development and regulatory decision-making. • Develop, verify, and apply PBBM and PBPK models using platforms such as Simcyp, GastroPlus or equivalent software., • Support the prediction and assessment of oral absorption, food effect, bioavailability, formulation bridging, dissolution and particle size specifications, and virtual bioequivalence., • Perform model calibration, sensitivity analyses, scenario testing, and uncertainty assessments to support project decisions., • Collaborate with laboratory scientists to design and interpret in vitro studies supporting model development and verification., • Support the development of clinically relevant dissolution methods and in vitro-in vivo links where appropriate., • Communicate modelling outcomes through technical reports, project team presentations, regulatory documents, and scientific publications., • Contribute to innovation in modelling methodologies, automation, and data-driven approaches, including AI/ML-enabled predictive tools where appropriate., • PhD or MSc in Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics, Pharmacometrics, Chemical Engineering or a related scientific discipline. For MSc candidates, substantial relevant industrial experience in PBPK, PBBM, pharmacometrics, mechanistic modelling or model-informed drug development is required., • Demonstrated expertise in PBPK, PBBM, pharmacometrics, mechanistic modelling, or model-informed drug development., • Strong understanding of oral absorption, dissolution, permeability, biopharmaceutics, and pharmacokinetics., • Experience with PBPK/PBBM modelling software such as Simcyp, GastroPlus, PK-Sim or similar platforms., • Demonstrated ability to apply modelling to solve pharmaceutical development challenges., • Strong written and verbal scientific communication skills., • Evidence of scientific productivity through publications, presentations, technical reports or regulatory contributions., • Experience supporting regulatory submissions involving PBPK or PBBM analyses., • Experience with virtual bioequivalence or clinically relevant dissolution specifications., • Working knowledge of Python, R, MATLAB, or other scientific programming tools., • Experience applying machine learning or data science approaches to pharmaceutical development., • Experience across multiple drug modalities, including poorly soluble compounds, enabling formulations, peptides, or complex dosage forms. For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors. PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law. PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances. We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us. Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation. Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793. #J-18808-Ljbffr