Pharmaceutics Scientist

Pharmaceutics Scientist

Eurofins

Macclesfield, United Kingdom

Job Description

• The purpose of this role is to technical support during the transfer of manufacturing processes for established products (OSDs) within Client sites and to external manufacturing partners.
• Lead, assess and support investigations on manufacturing processes deviations and on market complaints, ensuring suitable corrective and preventative actions are identified.
• Identify opportunities for manufacturing process improvements, including increase of yield, reduction of lead time, reduction of carbon footprint, reduction of CoG.
• Lead, assess and support implementation of approved complex technical improvements and change projects assuring product and methods performance.
• Support lifecycle activities (e.g. change control, continuous process verification, support to GMP inspections) for products under your accountability, to ensure performance and compliance across sites.
• Contribute to regulatory file authoring and review, to support regulatory variations, license renewals and response to questions from regulatory Authorities.
• Actively share knowledge and experience and contribute to the overall growth of the analytical skills in the client service area.

Qualifications

• Degree, Master degree or PhD level with experience post degree in an appropriate discipline such as Chemistry, Pharmacy, Chemical Engineering, Pharmacy, Pharmaceutical Sciences or similar discipline.
• Good understanding of OSD products life-cycle from late stage development to launch and through the commercial life cycle.
• A technical understanding of raw material, intermediates, API and drug product manufacturing steps.
• A broad range of analytical understanding in line with material science and formulation.
• Understanding of critical factors including the precise replication of process parameters that influence physical properties and hence product quality, yield, manufacturability and bioavailability.
• Ability to interrogate data.
• Strong networking skill with the ability to communicate across functional boundaries and influence others to achieve results.

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