Parenteral formulation and Process Development Scientist
CTC Resourcing Solutions
- Bâle
- Contrat
- Temps-plein
- Lead the design, planning, execution, interpretation, and reporting of formulation and process development activities for liquid and lyophilized parenteral drug products, encompassing small molecules, biologics (e.g., oligonucleotides), and long-acting injectables within a collaborative, multifunctional project team framework led by a Project Leader.
- Manage and oversee all project activities, providing support to team members, actively participating in sub-teams, and contributing to overarching TRD (Technical Research and Development) strategies and objectives.
- Independently plan, execute, and document scientific experiments with minimal supervision, meticulously documenting raw data, interpreting results, and proposing subsequent experimental designs while supervising project-related activities.
- Draft and review protocols, scientific reports, and process documentation (e.g., development reports, regulatory document support), ensuring meticulous attention to detail and adherence to regulatory standards.
- Spearhead the development and optimization of new methods and processes, contributing to the implementation of cutting-edge technologies and methodologies within the organization.
- Effectively communicate, troubleshoot, and resolve challenges within the scope of responsibility, fostering seamless collaboration across organizational interfaces, and facilitating knowledge transfer to other departments or external stakeholders through comprehensive training and support.
- Participate actively in function-specific sub-teams, fulfilling assigned project tasks and responsibilities in alignment with organizational objectives.
- A valid working/residency permit or Swiss/EU-Citizenship is required.
- Ph.D. in Chemistry or related disciplines with a minimum of 2 years of biopharmaceutical experience in Oligonucleotide (mRNA, siRNA, ASO) or Biologic field (ADC, proteins), OR Master's degree with at least 5 years of biopharmaceutical experience, OR Bachelor's degree with a minimum of 8 years of biopharmaceutical experience, each demonstrating expertise in formulation development (parenteral, aseptic, solution, and/or suspension) and manufacturing process or related competencies.
- Proficiency and familiarity with extra-hepatic oligonucleotide delivery is highly desirable.
- Hands-on experience in aseptic Drug Product manufacturing of oligonucleotides, including process transfer and Quality by Design (QbD) principles, is preferred.
- Experience with devices such as pre-filling syringes, vials, and combination products is advantageous.
- Proven track record in conducting in-use compatibility studies and preparation of Instruction for Use (IFU) documentation.
- Familiarity with process development and regulatory considerations in parenteral Drug Product clinical-grade manufacturing is considered a significant asset.