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Execution and / or coordination of (specialized) process development tasks for complex parenteral formulations

RESPONSIBILITIES

• 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. Lead or support the teams that drive change, uphold transparent communication towards department and site leadership.
• Build high performance teams by supporting personnel development for peers and leaders inside and outside of the department e.g., through authoring and scheduling training, giving feedback, providing input for the Performance Dialog, sharing best practices, continuous exchange across boundaries, supporting mitigation option definition, stakeholder management, and people empowerment.
• Support the department head or the site in organizational development e.g., task efficiency, resource allocation, business development definition, cross-departmental development.

REQUIREMENTS

• Five (5) or more years of directly related experience in process development in the pharmaceutical industry is required, experience in aseptic pharmaceutical manufacturing or development is a plus.
• 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; examples include reactor handling, extruder design, pumps, agitator design, process instrumentation, data collection, pilot plant operations, scale-up, etc.
• A thorough understanding and application of relevant scientific and engineering theories, principles, and methods; familiarity or general working knowledge of other related technical fields and applications as well as the capability to use and apply standard scientific and engineering procedures and techniques.
• A demonstrated ability to conduct assigned tasks independently with minimal oversight from management; utilize experience, knowledge, and technical creativity to independently determine and develop processes to meet project goals and objectives and resolve technical challenges; work on multiple activities in parallel and multi-faceted research studies or programs;; supervise other technical personnel in the execution of the above activities.
• 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; able to take corrective action to resolve technical problems of suitable 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.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

Your Application

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