[Overview:]{times="" new="" roman""=""}

[Oversee R&D staff in product development and product remediation/life-cycle management.]{times="" new="" roman""=""}

[* *]{times="" new="" roman""=""}

[Responsibilities:]{times="" new="" roman""=""}

[Work with pipeline/commercial development, project management, regulatory, and other department leads in the facilitation of deliverables. Review and assess active pharmaceutical ingredients technical packages, perform development studies in support of formulation development, evaluate data generated from formulation studies, lead the development of critical processing parameters, manufacturing processes, and proposed specifications. Provide clarity, remove obstacles, and manage/coach team in finding creative and innovative solutions to optimize/speed up development timelines. Direct scientific staff in developing strategies for new product development, and provide continued oversight on their execution to agreed timelines and quality standards. Communicate effectively and timely issues and solutions to R&D Leadership. Work with other department leads (pipeline/development, project management & regulatory) to provide technical input into product selection, and collaboratively work on defining product priorities and timing. Demonstrate scientific and people leadership, problem solving, and team building skills within the department and manufacturing plants. Provide technical expertise to a variety of projects to functional or small project teams in subject area, while have a strong understanding of analytical R&D activities. Develop conventional and complex products (e.g. suspension, emulsion, peptides), across multiple platforms including infusion bags and combination products. Use current R&D methodologies for the Design of Experiments and their statistical analyses. Work in product development in accordance with Quality by Design and Quality Risk Management principles. Generate product and process related documents, including but are not limited to protocol preparation, pharmaceutical development reports, investigations, and general technical reports supporting product development. Develop Technology Transfer strategy of formulation and process aspects that align with the Operations sites' capabilities. Ensure the delivery of a complete Formulation and Process Technology Transfer package to the site. Lead complex investigations at internal or external facilities. Maintain data integrity and ensure compliance with company SOPs, USP/Ph Eur, FDA, GDP and cGMP regulations. Investigate deviations and write exception documents. Complete data analysis and generate specification justification reports. Make sound technical recommendations regarding projects/issues and provide analysis of key experimental parameters. Independently select techniques and procedures to solve problems within the discipline of analytical chemistry and product development. Review and develop guidance documents for research and development activities. Maintain knowledge of relevant cGMP and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities. Conduct performance reviews, determine goals and Key Performance Indicators of direct reports, and manage career development and expectations. Work with HR on staffing, recruiting and employee relations. Conduct bioequivalence studies.]{times="" new="" roman""=""}

[* *]{times="" new="" roman""=""}

[]{style="f

"}