This Senior Process Scientist will be based at the Tullamore facility. This role is a permanent
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
- 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
- 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 firstname.lastname@example.org
The salary is negotiable and dependant on the experience of the successful candidate.