Manufacturing Science Specialist

Handles complex CAPA investigations related to manufacturing operations. In view of this:
– Uses Six Sigma and DMAIC methods where appropriate.
– Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).
– Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
– Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and procedures by defining, implementing and maintaining appropriate SOP’s and training.
– Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
– Defends investigations in front of regulators during audits.

Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this:
– Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate.
– Conducts risk analyses for existing bulk manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.
– Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation.
– Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
– Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and procedures by defining, implementing and maintaining appropriate SOP’s and training.
– Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
– Defends submissions in the role of recognized process expert.

As a recognized process expert:
– Is involved in technology transfers, CMO related activities
– Ensures training of personnel on Scientific & Technical topics

– Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience
– 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing, in a similar function
– Honest and responsible, flexible, customer focused, team player, open minded
– Critical thinking and Problem Solving
– GMP and bioprocessing knowledge and experience
– Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during an FDA or cGMP audit
– QbD, DIDOV, Lean, Six Sigma and DMAIC methods as appropriate

Open-ended contract

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