Formulation scientist responsible for the preparation and execution of experiments, data analysis and interpretation in a parenteral research and development setting.
Performing pre-formulation studies to build a robust understanding of the to-be-developed formulation.
Working with senior scientists to prepare and execute experimental designs, including data analysis and interpretation.
Planning and coordination development activities with analytical and process engineering colleagues.
Working with analytical experts to evaluate results from various formulation studies.
Engaging with various groups and technical services within operations and regulatory affairs to incorporate feedback during product development activities.
Authorship of technical and development reports, including technology transfer and regulatory submission documents. Where thoroughness and correctness are critical to successful transfer of products to operations sites.
Collaborating with process engineering on the optimization and scale-up of the manufacturing process
Knowledge of formulation development, materials characterization, process development, and scale up of sterile products.
Experience of Quality by Design (QbD) development principles is preferred.
Knowledge of common analytical techniques (HPLC, GC, etc.).
Knowledge of FDA and ICH guidelines and requirements of regulatory submissions.
Strong systematic and methodological approach to problem solving and troubleshooting.
Strong oral and written communication with clear awareness of efficient meeting and teleconferencing etiquette.
Ability to multitask and prioritize assignments and willingness to work in a cross-functional team environment.
Self-motivated, project ownership with ability to work under pressure to meet deadlines.
Computer literacy required, including e-mail and fundamental computer navigation. Proficiency in the use of Microsoft Office products including Word, Excel and PowerPoint.
BSc with 5 years’ formulation development experience;
MSc with 3 years’ formulation development experience; or