A Process Engineer/Scientist is required to work within the Process Development Commercial Support team. The team is responsible for providing process and product support to drug product formulation and fill-finish operations, acting as subject matter experts (SMEs) in drug product processes.
Key Responsibilities
The successful candidate will primarily support the following activities:
- Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
- Act as a key contributor to product and process investigations, assessing product and process impact.
- Lead continuous improvement projects to enhance process performance and productivity.
- Assess product impact associated with proposed changes to commercial processes under change control.
- Generate product impact assessments for process excursions and deviations with reference to product technical documentation.
- Support new product introduction (NPI) activities as a process SME, including recipe development, protocol execution, troubleshooting, and investigation support.
- Review and approve changes to operating procedures, electronic batch records, and product documentation.
- Conduct risk assessments and lead mitigation projects related to line performance.
- Perform process gap analyses and develop strategies to close identified gaps.
- Perform data trend analyses for key process performance indicators.
- Troubleshoot and resolve process performance trends.
- The successful candidate will work collaboratively within the process team structure and contribute as a member of cross-functional teams across the organization and wider network.
Basic Qualifications
- Bachelor's or Master's degree in Engineering, Science, or a related discipline, with at least 6 years of experience in a similar role, or a PhD with 3 years of directly related experience.
- Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Preferred Qualifications
- 4-6 years of drug product experience in areas such as formulation, vial/pre-filled syringe filling, or lyophilization.
- Qualification in Lean or Six Sigma methodologies is an advantage.
- Experience in New Product Introduction (NPI), Process Development, or MSAT within a GMP environment is desirable.
