Associate Director/Senior Manager, Process Research & Development
Leadership responsibility for coaching and development of a team of process chemists and contributions to the drug development process that resulted in achievement of key milestones in the drug development cycle. Leads scientists in multiple departmental sections. Assists in establishing process chemistry departmental R&D plan and overall drug substance budgetary process. Understanding and utilization of novel technology platforms such as flow chemistry and catalysis. Responsible for the TCG GreenChem, Inc. global API supplies from Phase I up to commercial. Ensures achieving bottom-line company business goals by delivering economical API processes in a timely manner for CDMO business.
- Provide leadership to multiple departmental sections, stressing the competencies of analytical thinking, communication, continuous improvement/learning, teamwork, and business and technical competence.
- Provide effective management to the sections with the goal of meeting R&D project milestones and accomplishing other projects in alignment with R&D and global goals and objectives, stressing the competencies of coaching and developing others, customer focus, delivering results, and planning and organizing.
- Provide leadership to the sections and Process R&D Department in recruiting, retaining, and developing quality staff.
- Participate in managing departmental capital and operating budget. Manage and adjust activities of the sections to operate within budgetary goals.
- Participate in the overall management and leadership of the Process R&D Department by providing support to the Departmental Head, and by assuming specific responsibilities for departmental operations.
- Participates in establishing departmental strategic and operational R&D plans. Proposes and opens up new areas of R&D creatively and independently.
- Participates in multidisciplinary/international projects and meetings. Independently represents department on functions and project teams for clients. Informs senior levels of progress and initiatives.
- Maintain outstanding, nationally recognized scientific output as evidenced by an appropriate number of publications, patents, and outside invited presentations.
- Complies with established SOPs and procedures and appropriate GMP regulations, training, safety, personnel policies, intellectual property, and corporate policies.
- Ph.D. degree in synthetic chemistry with 7+ years of pharmaceutical industry process chemistry experience, including managing process research programs.
- Requires the ability to propose and evaluate new areas of process research creatively and independently. Requires broad and thorough understanding of process chemistry area and of all relevant literature.
- Requires the ability to communicate effectively: Requires the ability to prepare technical reports, publications, patents, and oral presentations. Requires the ability to communicate results both internally and externally.
- Requires the ability to lead and participate in interdisciplinary and/or international teams.
- Requires the ability to manage all aspects of section operations. Requires the ability to lead and to develop process chemists. Requires the ability to manage all levels of process chemistry scientists as required.
- Requires understanding of all applicable regulations related to GMP environment.
- Excellent verbal and written communication
- Critical thinking
- Problem solving
- Active listening
- Out-of-the-box thinking
- Knowledge of regulatory requirements
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