Senior Formulation Scientist

Summary

The Senior Formulation Scientist is responsible for formulation development, qualifying new raw materials, recommending specifications for products and evaluating product manufacturing instructions. The SeniorFormulation Scientist also maintains the laboratory and all documentation within GLP / cGMP guidelines.

Essential Duties and Responsibilities

• Design and perform experiments leading to the development of rational, scientifically sound formulations and manufacturing processes.
• Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices.
• Conduct research and experimentation on substances for such purposes as product and process development.
• Support the qualification, calibration and maintenance of production equipment in accordance with GLP / cGMPs.
• Ensure compliance with product quality, safety, performance and efficiency.
• Review compendia requirements for use of excipients.
• Interpret protocols necessary to complete projects.
• Possess comprehensive knowledge of techniques in areas of solid, liquid and semi-solids dosage forms supporting formulation development.
• Formulate and scale up all aspects of solid dosage forms including wet and dry granulating, compressing, coating and printing.
• Assist with maintaining an organized laboratory.
• Prepare and review scientific documentation such as, laboratory notebooks, data analysis, regulatory reports, master formulas, manufacturing procedures, product development reports and SOPs.
• Prepare written reports for regulatory filings and documents all formulation activities pursuant to cGMP standards.
• Provide leadership to team members when appropriate.
• Interface with business partners to provide assistance with their requests.
• Develop systems that are cost effective and increase efficiency.
• Maintain current knowledge of cGMP documents and guidance, other FDA / ICH guidance and SOPs.
• Provide support and guidance to the Production department and oversees the manufacturing of first-time products using production equipment.
• Coordinate with analytical chemists in Research Services for completing testing of new drug products in a timely manner and developing appropriate controls.
• Interface with all other departments as necessary.
• Report significant observations, recommendations and conclusions pertaining to areas of responsibility.
• Recommend potential actions to correct deviations from the norm.
• Represent the company through contact with outside groups and may establish beneficial relationships.
• Participate actively in seminars and professional society meetings.
• Adhere to set safety standards.
• Participate as a team member, support the company mission and vision and contribute to the pursuit of the company's goals.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned.