Description
Role
For my client near Amsterdam i am looking for a freelance consultant with a strong knowledge and experience of bio-process engineering for an assignment within their technology centre focused on supporting production, including troubleshooting, transfer of process technologies, and improvement of manufacturing processes to increase yield and quality.
Main responsibilities:
Design approaches to identify and resolve production problems and requirements. Apply all aspects of Good Science in laboratory and scale-up studies. Proficiently perform multiple laboratory experiments for development studies. Responsible for aligning plans and strategy with the manufacturing department.
Write technical and regulatory documents appropriate to project level. Present data clearly and thoroughly in both one-on-one and group meetings with clear and precise graphs/charts/tables and provide written summary reports as appropriate. Interact with other groups and share information; participate in team activities.
Supervise technical personnel. Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities. Be able to guide and control external studies at Contract Research Organizations. Provide technical support as a Subject Matter Expert to cross-functional teams and Product Support Work Streams, as well as problem solving for a given Active Pharmaceutical Ingredient (API) or drug product.
Skills and experience required:
Knowledge of bioprocess engineering. Knowledge of downstream bioprocess development. Affinity with flow-through density centrifugation. Is knowledgeable of basic compliance requirements. Problem solving abilities. Scientific report writing skills. Knowledge of regulatory issues involved with Chemistry, Manufacturing and Controls (CMC). Good organizational skills. Excellent communication (oral and written) and interpersonal skills. Functions as a team player. Has knowledge of related areas of development to incorporate into local problem solving. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment.