Senior or Principle Scientist / Engineer, Technical Operations
Our client is a multinational pharmaceutical company operating a busy high performing global supply chain operation in Dublin. This newly created role will be permanent based.
Technical Operations is the organization within Global Manufacturing & Supply (‘GMS’) responsible for ensuring that externally sourced pharmaceutical products are scientifically robust, manufactured under control and remain in a constant state of validation throughout their product lifecycle in order to maintain a consistent supply of safe and effective products to patients.
The Senior Scientist/Engineer of Manufacturing Science and Technology provides proactive support to enable 5 Technical Operations pillars. Responsibilities include:
- Provides technical support to R&D support during manufacturing scale-up, process/packaging validation and launch of new products at external manufacturing organizations (EMOs).
- Provides technical research and process knowledge in the implementation of change controls and technical transfers.
- Monitors process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control.
- In collaboration with Quality, supports the accurate execution of routine process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
- Supports a continuous process verification program for assigned projects via the collection and trend analysis of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) at EMOs
- Collecting and analysing key performance indicators (KPIs) to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
- Providing scientific leadership of technology transfers to/from external manufacturing sites to ensure right first-time transfers.
- Authors technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes.
- Contributes scientific guidance during process/product deviations, out-of-trend/ out-of-specification (OOT/OOS) investigations and product complaints.
- Use scientific and statistical analyses (of KPIs) to develop process understanding. Uses knowledge further in root cause analysis investigations.
- Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products.
The following attributes are necessary:
- Bachelor’s degree in in Chemistry, Chemical Engineering, or Pharmaceutical Chemistry with minimum 7 years of experience or master’s Degree with 5-7 years of experience or Ph.D. with 3-5 years of experience in Pharmaceutical Technical Services encompassing Technical Transfer, Technical Trouble Shooting and Process Optimization.
- CMC Subject Matter Expertise across a broad range of pharmaceutical dosage forms
- Demonstrated industry experience supporting approved commercial products.
- Direct experience with transferring technology and products from R&D to manufacturing.
- Strong trouble shooting skills
- Must be action oriented, make informed decisions and be self-motivated
- Working knowledge of databases. Ability to utilize Minitab or other statistical analysis software as needed.
- Understanding of CMC regulatory requirements and technical risk management.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Ability to detect and resolve problems, own decisions, and accomplish tasks/goals.
- Ability to quickly change priorities and deliver targeted support.
- Ability to present complex scientific information to a business audience.
- Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment.