Senior Scientist (f/m/d) Process Development Drug Product

Your Responsibilities:

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• Development, optimization and down-/upscaling of GMP-compliant manufacturing processes and control strategies for formulated RNA products
• Scientific lead of knowledge generation of drug product processes regarding the impact of process parameters on CQAs of the drug product (e.g., setting operational ranges, failure mode)
• Planning, execution, interpretation, documentation and communication of experiments using suitable scientific approaches (e.g., feasibility, OFAT, DoE, etc.)
• Contribution to the development of bio- and physicochemical characterizations of formulated nucleic acids and process-related impurities
• Support of process development at C(D)MOs as well as technology transfers to GMP production sites and/or other business partners
• Preparation and peer review of development reports, risk analyses (e.g., FMEA), manufacturing description, laboratory instructions, training documents and SOPs
• Managerial line for a team of scientists, engineers and TAs (e.g., goal-setting, coaching, regular feedback, appraisals, design and implementation of personal development plans)

Your Qualifications:

• Bachelor/Diploma with PhD in Engineering, Chemistry, Pharmacy or equivalent
• Profound experience in the industry environment in the development of process of pharmaceutics (either API or DP)
• Knowledge and understanding of ICH, GMP and agency-specific (FDA and EMA) guidelines
• Technical pharmaceutical skills and experience in several relevant topics such as: DoE, statistics, risk assessment, filtration and tangential flow filtration, mixing, lipid- or polymer-based drug delivery systems, sterilization and aseptic process
• Understanding of basic project management concepts is desirable (e.g. planning, critical chain project management, risk assessment, budgeting, communication)
• First leadership experience is highly desirable (e.g., goal-setting, appraisal, driving change)
• Proactive, structured, positive and independent way of working
• Strong communication skills and team orientation
• Fluency in English; German is a plus

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us – become part of the RNA people!   

We look forward to receiving your application via our CareerPortal.

CureVac RNA Printer GmbH

Human Resources
Julia Daake 
Friedrich-Miescher-Straße 15
72076 Tübingen