This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Execution and / or coordination of (specialized) process development tasks for complex parenteral formulations
Job Responsibility:
Oversee and support multiple internal and customer projects and sub-projects with the focus on engineering solutions, project planning, resourcing, and execution with respect to timelines and budgets
Own complex parenteral formulation projects in the role of the technical lead of a larger cross-departmental team in regard to onboarding, engineering design, process development, GMP readiness and execution in non-GMP and GMP environment
Drive department knowledge and capability by regularly reviewing state-of-the-art information, detecting opportunities for future business and aligning with all relevant stakeholders
Drive change by detecting, defining and owning improvement ideas in technical areas, as well as business process related areas
Build high performance teams by supporting personnel development for peers and leaders inside and outside of the department
Support the department head or the site in organizational development
Requirements:
Five (5) or more years of directly related experience in process development in the pharmaceutical industry is required
A minimum MS in a relevant engineering field (e.g. pharmaceutical engineering, chemical engineering)
or a BS in a relevant technical field with a sufficiently demonstrated level of performance and capability, as determined by management
Knowledge of the scientific and engineering principles pertaining to and capable in the operation of standard laboratory, analytical, and/or processing and manufacturing equipment
A thorough understanding and application of relevant scientific and engineering theories, principles, and methods
A demonstrated ability to conduct assigned tasks independently with minimal oversight from management
Capable of conducting engineering studies, data analysis, and creating technical reports and presentations
Recognize unanticipated or adverse outcomes or deviations
able to use technical expertise, experience, and creativity to evaluate and identify causes of unanticipated or adverse outcomes or deviations and to propose corrective action or resolutions for problems of increasing complexity
Experience contributing to department and site continuous improvement initiatives regarding policies, procedures, workflows, process standardization, etc.
Knowledge of cGMPs, phase appropriate regulatory requirements, and the ability to appropriately scope complex parenteral formulation development projects with respect to technical scope, time, and budget
General knowledge of several fields across the pharmaceutical product development process, multiple drug delivery technologies, or multiple analytical technologies
Experience designing and conducting studies based on statistical Design of Experiments principles.
Nice to have:
experience in aseptic pharmaceutical manufacturing or development is a plus