Fort Worth Metro Area, TX
Lead and manage all assigned project activities related to sterile primary package development and participate in project and functional unit teams. Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of sterile primary packaging, processes and procedures.
1. Actively participate in teams, projects, networks and/or platforms. Actively contribute to team goals. Fulfill related tasks and responsibilities related to own discipline and ensure all own activities are aligned with overall drug development process. Contribute to risk analyses and/or peer review and process challenge meetings. Interact/collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and deliveries primary packaging.
2. Design, plan and perform scientific experiments. Provide efficient and robust processes for the manufacture and/or analysis of primary packaging. Interpret results, evaluate data, draw relevant conclusions, and write reports
3. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Proactively contribute to setting, updating and monitoring of team goals.
4. Translate team goals into daily work. Support, engage and drive culture change consistent with organization values and objectives. Consistently demonstrate good change management practices to protect product quality.
5. Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines. Provide quality documentation and assessments in a timely manner.
6. Participate in grant preparation and tracking of invoices. Demonstrate cost awareness in all assigned projects and/or networks.
1. 3+ years of packaging experience in the Pharmaceutical and Medical Device industry developing solutions and leading packaging and/or device programs.
2. Thorough understanding of development processes in sterile primary packaging development.
3. Ability to work in and/or lead teams.
4. Strong leadership skills.
5. Strong knowledge of relevant SOP, GLP andGMPregulations and policies.
6. Very good communication skills. Good presentation skills and scientific/technical writing skills.
7. Excellent knowledge of laboratory and/or technical tools. Good knowledge of software and computer tools.
Minimum: BS or equivalent in Packaging, Engineering or applicable discipline.
Desirable: Advanced degree in a scientific or relevant discipline (M.S. or equivalent).