EMD Serono is looking for an Analytical Development Senior Analyst to serve as a key technical reference for maintaining and optimizing analytical methods. You will ensure method consistency, robustness, and alignment with global and regulatory standards within our diverse and innovative environment.
What You'll Do
- Act as a technical reference in the maintenance and optimization of analytical methods, ensuring consistency, robustness, and alignment with global and regulatory guidelines.
- Conduct and review studies related to analytical method validation, forced degradation, impurity profiles, and pharmaceutical equivalence.
- Perform critical assessments of technical documentation for local and global projects, ensuring compliance with ANVISA, ICH, and corporate standards.
- Provide technical support to Regulatory Affairs and Compliance teams, offering guidance for closing gaps, DMF, and other analytical topics.
- Collaborate with different site areas and global teams, promoting clear communication, alignment of expectations, and risk-based decision-making.
What We're Looking For
- Complete degree in Pharmacy, Chemistry, or Chemical Engineering.
- Solid experience in analytical techniques and Good Laboratory Practices (GLP).
- Robust knowledge in method validation, forced degradation, DMF, impurity profiles, and pharmaceutical equivalence.
- Fluent English (mandatory), with the ability to read technical documentation and interact with global teams.
- Collaborative profile with clear communication and ability to influence and coordinate different stakeholders.
- Proactive attitude, with senior posture and autonomy for technical decisions.
Team & Environment
We are curious minds from a wide range of backgrounds, perspectives, and life experiences. We believe this variety drives excellence and innovation. We are committed to creating access and opportunities for everyone to develop and grow at their own pace, building a culture of inclusion and belonging.
