Assist in process development activities of new products for non-clinical to commercialization with adherence to Current Good Manufacturing Practices (cGMPs).  Gather data from Design of Experiments (DOEs) and provide statistical analysis in assessing process performance.  Work with the Pharmaceutics team to take formulation projects to the lab coater and pilot coater accordingly. Scale up from the pilot coater to commercial scale equipment at the appropriate stage of development. Initiate process improvements to add defect detection, reduce cycle times, reduce cost, or improve product quality. Create detailed project timelines that include all cross functional activities until implementation. Communicate timelines and other technical activities in cross functional meetings. Write protocols, reports and present results in team meetings. Develop regulatory strategies and detailed project timelines for material qualifications until implementation. Implement raw material and finished product shelf life extensions.

• Assist in the development and coordination of experiments, including but not limited to DOEs to characterize and improve processes.
• Improve commercial processes by reducing waste, cycle times, and cost. Improve quality by building in quality by design and PAT to processes.
• Increase capacity in capacity limited production areas.
• Assist in process development for blending, coating, slitting and packaging of new products for Product Development.
• Compile data from DOEs and provide statistical analysis in assessing process performance.
• Perform drug calculations for controlled substances.
• Develop protocols, batch records, procedures to ensure successful project execution.
• Apply cGMPs as related to process design to ensure FDA compliance.
• Assist during product/process design and re-design in an effort to reduce costs to optimize technology transfer.
• Be prepared to represent authored documentation in FDA GMP audits.
• Interface with Engineering, Validation, Production, and customers to troubleshoot production processes and equipment issues.
• Work on product transfer projects.
• Provide timelines for scale up activities and new projects throughout the development process until implementation.
• Create strategies and detailed timelines for material qualifications.
• Cross train to pharmaceutics to understand material properties and formulation activities.
• Run pilot plant independently.
• Create manufacturing procedures for development and product transfer projects.

Competencies:

Ability to ascertain that work complies with approved Standard Operating Procedures and meets all guidelines of Noven Pharmaceuticals Inc.  Good written and verbal communication skills; highly organized.  Candidate must demonstrate computer skills with knowledge of office applications software, Mini Tab and enterprise software, attention to detail, ability to speak, read and writes in the English language.  The employee must demonstrate the ability to perform statistical analysis using Mini Tab. Experience with a project management system is preferred. Employee must demonstrate the ability of adhering to stringent cGMP and DEA documentation requirements.    Employee must have good interpersonal skills to interface with other internal groups. 

Education & Experience:

BS degree with five to ten years of relevant pharmaceutical experience required.   Knowledge of manufacturing processes steps and quality standards.   Knowledge of Six Sigma and statistical tools.