At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are excited to kick-off our Biotechnology project in Athens.
The field of Biotechnology is bringing about fascinating developments in medicine, treatments, and healthcare, as new, effective medicines are being produced from extremely complex natural compounds, with a biological origin. Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology
- We are building a prototype unit for the development of monoclonal antibodies
- We are creating a contemporary Research and Development Center for biotechnology
- We are starting research for three finished pharmaceutical products with monoclonal antibodies
- We are establishing a Biotechnology Academy to train young scientists. Biotechnology is becoming part of our lives.
As a result, We are seeking a talented and experienced Mass Spectrometry Supervisor to join our biosimilar development team. The Mass Spectrometry Supervisor will play a critical role in leading a team responsible for the design, execution, and interpretation of mass spectrometry experiments to support the development and characterization of biosimilar products. The successful candidate will possess a deep understanding of mass spectrometry techniques, excellent leadership skills, and a passion for advancing biopharmaceutical science.
Main duties and responsibilities:
- Lead and manage a team of scientists and technicians to conduct mass spectrometry experiments in support of biosimilar development programs.
- Develop and validate mass spectrometry methods for the characterization and quantification of biosimilar products, including peptide mapping, intact mass analysis, glycan analysis, and peptide sequencing.
- Design experimental protocols and workflows to address specific analytical challenges related to biosimilar development, such as comparability studies, forced degradation studies, and stability testing.
- Analyze mass spectrometry data, interpret results, and provide scientific insights to guide decision-making in collaboration with cross-functional teams.
- Contribute to internal trainings.
- Maintain and troubleshoot mass spectrometry instrumentation, ensuring optimal performance and adherence to regulatory requirements.
- Stay current with developments in mass spectrometry technology and industry best practices, incorporating new methodologies and techniques as appropriate.
- Contribute to regulatory submissions by preparing technical documents, assay validation reports, and other supporting documentation in compliance with regulatory guidelines.
- Perform method validation, optimization, and troubleshooting to ensure robustness, accuracy, and precision of analytical assays.
- Interpret mass spectrometry data and collaborate with bioanalytical and biophysical scientists to elucidate structural and functional attributes of biosimilar molecules.
- Contribute to regulatory submissions by providing analytical data, reports, and documentation in compliance with applicable guidelines and regulations (e.g., FDA, EMA).
- Stay current with advancements in mass spectrometry technology and methodologies, and actively participate in scientific conferences and publications.
Requirements
- Ph.D. or M.S. in Analytical Chemistry, Biochemistry, or related field with 8+ years of industry experience in mass spectrometry, preferably in a biopharmaceutical or biosimilar development setting.
- Strong expertise in mass spectrometry techniques, including LC-MS, LC-MS/MS, and MALDI-TOF and data analysis software (e.g., MassLynx, Proteome Discoverer and etc…), with a focus on protein characterization and analysis.
- Proven leadership and project management skills, with experience supervising and mentoring scientific staff.
- Proven track record of applying mass spectrometry techniques to the analysis of protein therapeutics or biologics, preferably in a pharmaceutical or biotechnology industry setting.
- Demonstrated ability to design and execute complex experiments, analyze data, and communicate results effectively to diverse stakeholders.
- Familiarity with regulatory requirements for biopharmaceutical characterization, including ICH guidelines, FDA/EMA regulations, and industry standards.
- Excellent written and verbal communication skills, with the ability to collaborate effectively in a cross-functional team environment.
- Strong problem-solving abilities and attention to detail, with a commitment to delivering high-quality results on time and within budget.
- Strong understanding of protein chemistry, biophysical characterization techniques, and regulatory requirements for biosimilar development.
- Excellent problem-solving skills, attention to detail, and ability to work effectively in a fast-paced, collaborative environment.
- Excellent communication skills and ability to present complex scientific concepts to diverse audiences.
- Software knowledge like: excel, Empower, Data visualisation and statistics like: Graph Pad Prism, JASP, JMP or similar.
- Operating sophisticated analytical equipment like: Mass Spectrometers, UPLC, FTIR, CD.
- Experience in quality system – GMP, GLP or Good Development Practices will be an advantage.
- Critical thinking & problem solving
- Resilience and ability to work independently,
- Good communication skills and team player
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.