Senior Processing Scientist

Senior Processing Scientist
Posted 2 months ago

The Role

This Senior Process Scientist will be based at the Tullamore facility. This role is a permanent

Principle Duties

The successful candidate will be involved in

  • Support process scale-up and optimisation for manufacture of clinical and/or commercial products; prior hands-on experience in applying QbD principles and statistical analysis methodologies a plus.
  • Lead and/or support process validation including protocol write up and execution.
  • Perform technical transfer of specified unit operations to contract manufacturer and support external process scale-up activities.
  • Liaise with analytical/other relevant department personnel during manufacturing activities, optimization and scale-up
  • Involved in any technical issues and improvements.
  • Prepare batch records and execute production operations
  • Proficient in Technical report writing.
  • Follow good documentation practices and ensure they are followed
  • Ensure all work is carried out in compliance with company and regulatory standards.
  • Experience working with Investigational Medicinal Products.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Good working knowledge of Microsoft Word, Excel, Powerpoint.
  • Willingness to learn and ability to adapt to the needs of the business.
  • Good interpersonal and team working skills.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization with ability to escalate issues as required.
  • Demonstrates a positive attitude to work and uses time efficiently and effectively.
  • Participate in team meetings and work according to agreed timelines

Minimium Requirements

  • M.Sc/PhD in Chemistry, Pharmaceutical Sciences or related life sciences
  • Minimum 3/5 years of pharma industry experience (dependent on PhD/MSc degree, respectively)
  • Prior involvement in leading technical projects
  • Experience in process development, scale-up and tech transfer in oral dosage forms
  • Process Validation experience
  • Knowledge of QbD and DoE methodologies within product and process development in oral dosage forms
  • Strong knowledge of GMP requirements
  • Proactive, innovative with good problem solving skills.
  • Excellent interpersonal, collaborative, communication (written and verbal) and timemanagement skills are essential.
  • Results and Performance driven

Desirable Skills

  • Experience liaising with CMOs
  • Hands on experience in DoE/QbD software and in developing CMC control strategy for regulatory submission
  • Ability to travel up to approximately 10-20%, including internationally

How to apply

Suitable Candidates should submit a CV and cover letter by close of business, December 9th, 2019 to

The salary is negotiable and dependant on the experience of the successful candidate.

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