K-Recruiting Life Sciences

Formulation Scientist

Posted: 1 days ago

Job Description

Formulation Scientist (M/F/D) Tasks:Be accountable for all formulation and manufacturing process deliverables including scientific documentation, design of experiments of parenteral products, batch records, deviations, change controls, CAPAs, tech transfer, and reports.Drive DP development, manufacturing process transfers and supply activities with scientific and technological excellenceWork closely with cross functional teams both internal and external to provide technical input for the development and manufacturing process (including CRO and CMOs).Provide technical support to compile technical regulatory documentation and responses to regulatory agencies as needed.Assist with writing and reviewing of CMC documentation associated with project or manufacturing changes.Experience developing injectable drugs, including solutions, suspensions, and aseptic formulations. Knowledge of RNA-based therapies (e.g., siRNA, mRNA) and drug delivery systems like pre-filled syringes or vials.Skills in designing manufacturing processes and transferring them to production environments. Familiarity with aseptic drug manufacturing and methods like QbD.Experience in developing, optimizing and transferring freeze-dried products, including thermal analysis (DSC, FDM, XPRD), thorough understanding of cycle design and development (including model-assisted approaches), and scale-up from lab to pilot/commercial scale.Understanding of GMP and preparing technical documentation for regulatory submissions.Designing experiments (e.g., DoE) and analyzing data to improve formulations and manufacturing processes.Strong teamwork skills for working with internal teams and external partners (e.g., CROs/CMOs). Clear communication and ability to write reports, technical documents, and regulatory responses.Ability to handle deviations, implement corrective actions, and improve manufacturing processes.Interest in advancing RNA drug delivery platforms and contributing new ideas to the field.Qualification:Working knowledge of oligonucleotide-based therapies (e.g., ADCs, proteins, RNA-based drugs).Familiarity with process development for clinical-grade parenteral drug products. Proven experience in related fields such as pharmaceuticals, biotechnological product development, and advanced drug delivery platforms.Ph.D., Master’s or Bachelor’s Degree in Chemistry or related disciplines: With 2+ years (Ph.D.), 5+ years (Master’s), or 8+ years (Bachelor’s) biopharmaceutical experience.Proven expertise in formulation and manufacturing process development for parenteral and aseptic products, including lyophilized dosage forms. Demonstrated capability in lyo cycle development and optimization.Requirements: Start: asapDuration: 12 monthsCapacity: 5 days per weekLocation: Basel, Switzerland (100% on-site)

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