API EM TSMS Scientist
Join a dynamic and expanding Active Pharmaceutical Ingredient (API) External Manufacturing Organisation (EM) dedicated to delivering vital medicines to patients worldwide. As an API EM TS/MS (Technical Services / Manufacturing Science) Scientist, you will play a pivotal role in ensuring the reliable, compliant, and efficient manufacture of monoclonal antibody (mAb) drug substances within a fast-paced external manufacturing environment. Your expertise will support ongoing production, troubleshoot technical challenges, and drive continuous process improvements, making a tangible impact on patient health globally.
This opportunity is ideal for experienced professionals with a strong foundation in biopharmaceutical manufacturing, regulatory compliance, and cross-functional collaboration. Be part of a team that values innovation, technical excellence, and strategic partnerships-contribute your skills to advance life-changing therapies.
Required Skills:
- Bachelor's degree in Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry/ biotech strongly preferred)
- Minimum of 3 years hands-on experience in biopharmaceutical manufacturing with proficiency in process monitoring and troubleshooting
- Solid understanding of cGMPs, global regulatory standards, and pharmaceutical industry best practices
- Experience supporting monoclonal antibody (mAb) manufacturing processes
- Strong technical writing skills, including deviation reports and change controls
- Effective communication skills for managing internal and external stakeholder relationships
- Ability to operate within a validated or qualified manufacturing environment and justify process states with data
Nice to Have Skills:
- Deep knowledge of global regulatory guidance applicable to biopharmaceutical manufacturing
- Proficiency in data management and analysis within manufacturing operations
- Demonstrated adaptability and collaborative mindset
- Project management experience with a history of coordinating multifaceted initiatives
- Experience working with cross-functional teams across different time zones
Education and Experience:
- Bachelor's degree or higher in relevant scientific disciplines
- 3+ years of relevant experience in biopharmaceutical or biologics manufacturing
- Proven ability to support large molecule (mAb) processes in a regulated environment
Other Requirements:
- Flexibility to support off-shift work, including nights and weekends, to ensure 24/7 manufacturing and issue resolution
- Ability to collaborate effectively with international partners and cross-functional teams
If you're passionate about advancing biopharmaceutical manufacturing and committed to maintaining the highest standards of quality and compliance, we encourage you to apply or contact Jenny Murphy. Take the next step in your career and contribute to life-changing medicines on a global scale!
