Summary:
This role involves providing Process Development support for syringe filling and Single Use Technologies development for drug product Formulation & Filling processes. Key projects include the characterisation and qualification of filling technology and new single-use technology for new syringe filling lines as part of a site expansion project. The candidate will provide technical support to drug product manufacturing, as well as part of the global Process Development (PD) organisation.
Responsibilities:
- Developing single-use systems in collaboration with site teams and network for drug product formulation and filling.
- Authoring/verification of single-use qualification packages.
- Filling characterisation support (Filling recipe development - protocol development/execution and reporting).
- Providing leadership to cross-functional teams to advance complex projects to completion.
- Leading and conducting risk assessments for drug product operations and proposing/implementing appropriate CAPA.
- Providing process development expertise for drug product processing in specific areas such as sterile processing, process characterisation, filling, SUS.
- Troubleshooting issues with drug product processing technologies and equipment.
- Leading or assisting in deviation/exception resolution and root cause analysis.
- Ensuring that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
- Reviewing and post-approving process validation protocols and assessments from a quality system documentation perspective.
- Contributing to product quality assessments and process flow documents.
- Liaising with Operations, Engineering, and external vendors regarding new or amended equipment that would impact the validated process.
Qualifications:
- A third-level Bachelor's Degree in Science, Engineering, or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Thorough knowledge of aseptic manufacturing technologies and cGMP.
- Problem-solving ability and excellent oral and written communications skills.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single Use systems and Filling.
Preferred Qualifications:
- 10+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer (to commercial DP sites), or Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation, and process validation of formulation, mixing, filtration, and filling. Knowledge of protein biochemistry regarding chemical and physical stability.
- Background in Drug product Filling technologies, Peristaltic pumping/Time pressure filling.
- Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.
