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Senior Development Scientist

Job LocationRuncorn
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Product Development ScientistAbout 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 site
  • Duties 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
  • Skills and experience:
  • Bachelors degree in a science related field, preferably with pharmaceutical formulation / process technology focus.
  • Experience within a regulated pharmaceutical environment
  • Experience in pharmaceutical process development, formulation and working cross functionally represents an advantage
  • Experience in project management represents an advantage
  • Demonstrate business-focused behaviours and pro-active attitude to work
  • Ability to communicate effectively and clearly, to resolve issues
  • Ability to prioritise and make critical process decisions at short noticeKey performance Indicators
  • Adherence to development project plans
  • Right first time on quality and performance
  • Adherence to health and safety performance targets
  • Required skills
  • Formulation
  • GMP
  • Manufacturing
  • Pharmaceutical
  • Production
  • Keyskills :
    Fmulation GMP Manufacturing Pharmaceutical Production

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