Formulation and Process Development Manager
Full Time (San Diego)
- The new hire will report to Chief Executive Officer. The successful incumbent will work on formulation and process development for parenteral and topical biological drugs based on our core nanotechnology platform.
- Develop robust parenteral and topical biological products and their manufacturing processes following the Quality by Design (QbD) Principle.
- Timely deliver the products and scale up manufacturing processes to support analytical development, nonclinical studies and clinical studies.
- Use risk management and QbD to build the quality within the process and product for the planned biological products.
- Develop and build the Formulation and Process Development Team over time.
- Responsible for all formulation and process development activities including plan the DoE studies, optimize and develop robust formulations and process, scale up activities, and technology transfer and validation activities.
- Prepare, review and verifying reports, process documentations and batch records.
- Build strong collaborative relationship with other departments: Analytical and Quality Control, Quality Assurance and Regulatory Affairs, and other collaborators.
- Strong scientific background in formulation development and process development for biological drugs.
- Self-motivated creative problem solver and can deal with ambiguity and declare a path forward to achieve results.
- PhD, master, or bachelor degrees in pharmaceutics, biomedical engineering, biochemical engineering, chemical engineering, molecular biology, cell biology, chemistry or any equivalent major.
- Ph.D. with over 5 years, master with over 8 years, or bachelor degree with over 15 years of experience in pharmaceutical or biotechnology companies.
- Prior experience formulation development for parenteral and topical formulations and process development for preclinical and clinical development projects.
- Hands on experience of cGMP aseptical manufacturing of lyophilized parenteral products.
- Experience in using DoE and QbD for product and process development.
- Experience in following ICH Q7, 8, 9, 10 and 11 for product and process development.
- Knowledge and understanding of cGMP regulations and FDA guidelines.
- Background knowledge and technical skills in nanotechnology and nanoparticle testing is a plus.
- Excellent verbal and written communication skills. Experience in writing reports, procedures and batch records.
- Team player with ability to positively communicate with team members
- Must be highly organized and able to work independently in a fast-paced environment under limited supervision
- Must be professional, dedicated, detail-oriented, and self-motivated
- Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP or Minitab etc.)