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Senior Development Scientist posted by Marketplace Technical

Runcorn, Cheshire

Job Description

Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Product Development Scientist

About the role:

Supporting the completion of product formulation studies at bench, pilot and commercial scales
Supporting the completion of process development studies at all scales
Review and interpretation of laboratory data
Generation of product development protocols, reports and associated quality documentation
Generation and periodic review/update of Standard Operating Procedures
Supporting development production activities at all scales throughout the siteDuties may include:

Maintenance of project management documentation
Supporting continuous improvement projects, throughout the site
Validation and qualification of equipment and processes
Maintaining current good manufacturing practice (cGMP) within the department as necessary
Adherence to site quality and safety policies
Responsible for execution and reporting of product development programs
Complete product development studies in accordance with statistically designed experiments
Support of development production activities at all scales throughout site and working cross functionally to ensure successful completion
Preparation and review of GMP related documentation (Protocols, reports, standard operating procedures)
Statistical analysis and interpretation of data
Support manufacturing and technology transfer activities
Providing information to support updates to management presentations as requested at scientific or project review meetings
Ensure full and free communication of project tasks and timelines
Escalate and resolve project issues in a timely manner
Ensure that the correct GxP standards are followed
Provide technical support and guidance to analytical teams as required
Provide technical support to the regulatory affairs group to assist in regulatory filings
Identify and contribute to continuous improvement initiatives and activities
Perform and assist in additional duties as directed by the management

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