What does a Principal Scientist - Formulations do?
Formulation scientists develop and text test mixtures of different compounds to determine necessary components and quantities to produce the desired effect. They create and implement formulation development strategies for products like solid dosage generic drugs and work with the development of generic pharmaceutical formulations. They also manage the product development process, and coordinate with strategic heads for sourcing development, quality assurance in manufacturing, and other teams involved in scheduling and planning.
Formulation scientists plan and conduct scientific experiments to create prototype products; they develop experimental programs and work to achieve their performance objectives. They are responsible for identifying complex problems and offering effective solutions through the development or modification of test methodology. They conduct laboratory experiments and prepare reports with conclusions and recommendations. Formulation scientists need a minimum bachelor's degree in chemistry or related fields.
- Responsible for all aspects of formulation and drug product development projects including early and late stages.
- Serve as a subject matter expert in lyophilization process and formulation design and optimization.
- Collaborate with various teams to move drug products from preclinical through commercial stages.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
- Comply with the company code of conduct and policies and regulatory standards.
- Serve as a scientific and technical mentor to junior level scientists.
- Review and write master batch records with input from supervisor.
- Work with various functional areas to ensure completion of development and manufacturing activities.
- Generate, analyze data and results and contribute to the recommendations for next steps based on the data.
- Design, execute, and analyze experiments for existing and novel modalities.
- Develop and optimize manufacturing processes and manufacture clinical supplies.
- Report and present scientific/technical results internally and to external clients.
- Responsible for the close and effective coordination and tracking of formulation and process development activities under tight program timelines with cross-functional accountability and interdependence.
- Lead experiments to confirm robust process performance across the control space.
- Responsible for establishing the basis of formulation and manufacturing process with relevant attributes and specifications as required to achieve the goal.
- Contribute to internal research and intellectual property projects and initiatives.
- Provide support for analytical development through the Product development cycle.
- Bachelor's Degree or higher in biological sciences, chemistry, or chemical engineering.
- Advanced protocol writing experience.
- Extensive experience with HPLC analysis, stability testing, and parenteral medicine development.
- Strong experimental design skills.
- Requires meticulous attention to detail.
- Proficiency with Microsoft Excel.
- Strong critical thinking and problem solving abilities.
How much does a Principal Scientist - Formulations make?
Principal Scientist - Formulations Career Path
Learn how to become a Principal Scientist - Formulations, what skills and education you need to succeed, and what level of pay to expect at each step on your career path.
Average Years of Experience
Principal Scientist - Formulations Insights
“Pay rate is not very good”
“Not good for personal professional development”
“No option to work from home”
“Some really great folks to work with”
“compensation is much lower for FTC”
“life balance is good”
“Few opportunities for development”
“Good for initial career to learn.”
Principal Scientist - Formulations Interviews
Frequently asked questions about the roles and responsibilities of a Principal Scientist - Formulations
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