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Job Description

Research Scientific Associate Director - Process Development

Join us

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. 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.

Opportunity

As 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 Responsibilities

• Independently 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 requirements
• Oversee 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 development
• Strategize and drive the internal PD software tool set to make process development more efficient
• Coach 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 absence

Job Requirements

• PhD degree of chemistry, biochemistry, biology, biotechnology, chemical/process engineering or related fields is required
• 10+ years of Pharm Sci pharmaceutical/biotechnology industry experience is required
• Scientific knowledge in process development and about plasma derived therapies fractionation and purification processes
• Experienced CMC Drug Substance matrix lead Demonstrated experience in statistical/mechanistical/hybrid modelling
• Solid knowledge in GxP
• Demonstrated ability to work as an individual contributor and in dynamic team environments
• Solid presentation skills
• Solid oral and written English and German communication skills required
• Basic knowledge of DFSS concepts beneficially
• Advanced modelling (process and/or protein modelling) and data analysis / management

Motivated 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.

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