Research Scientific Associate Director - Process Development

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A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.OpportunityAs a Research Scientific Associate Director you will be responsible for driving new, innovative programs to improve the process, and product quality of plasma-derived therapies, optimized for patients fully independently. This includes evaluation and process development of new products, alternative fractionation technologies and extraction of new plasma proteins.Job ResponsibilitiesIndependently lead pipeline programs across feasibility, early-/late-stage process development, and CMC clinical development studies, providing scientific guidance to support commercialization activities. Develop and implement risk-mitigation strategies; set strategic goals and objectives for product manufacturing operations; strengthen cross-functional collaboration and prioritization; and ensure ongoing compliance with all relevant regulatory requirementsOversee end-to-end project plan execution in close collaboration with internal and external stakeholders, defining scope, tasks, timelines, budget, and cross-functional interfaces (AD, DP, QA, RA, Manufacturing, MSci) to ensure successful delivery.Act as a Lead and SME for process development, optimization, characterization, QbD and tech transfer activities.Collaborate on and review technical documents including protocols and reports, risk assessments and provide input for master batch records, changes, and deviations. Authoring and revision of submission documents.Drive and further develop the way statistic/mechanistic/hybrid modelling, data science exchange is supporting PD team and continues to revolutionize the quality but also the speed of drug substance developmentStrategize and drive the internal PD software tool set to make process development more efficientCoach and develop staff, while driving workflow improvements to eliminate inefficiencies; mentor Research Scientists to strengthen process development and promote knowledge sharing.Support vendor management (including qualification CDMO visits), provide management updates, and manage external R&D collaborations from design through execution, data review, and close-out.Act as stand in for Head of PDT Process Development during absenceJob RequirementsPhD degree of chemistry, biochemistry, biology, biotechnology, chemical/process engineering or related fields is required10+ years of Pharm Sci pharmaceutical/biotechnology industry experience is requiredScientific knowledge in process development and about plasma derived therapies fractionation and purification processesExperienced CMC Drug Substance matrix lead Demonstrated experience in statistical/mechanistical/hybrid modellingSolid knowledge in GxPDemonstrated ability to work as an individual contributor and in dynamic team environmentsSolid presentation skillsSolid oral and written English and German communication skills requiredBasic knowledge of DFSS concepts beneficiallyAdvanced modelling (process and/or protein modelling) and data analysis / managementMotivated employees must be remunerated appropriately. The minimum annual salary for this important and responsible position is 110,200 gross per year (full time). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.Our employees benefit from an attractive range of benefits designed to support their wellbeing and lifestyle. Benefit eligibility varies by position and can include, amongst others: Training and continuing education, health and sports programs, meal subsidies, Employee discounts, Group accident insurance, Global Wellbeing Program, Employee Recognition Program, Employee Referral Program, regular company events, and much more.LocationsAUT - Wien - Industriestrasse 72Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeReference: R0183666