R&D CMC - Biotechnology

At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are excited to kick-off our Biotechnology project in Agios Stefanos.

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 currently looking for a motivated and experienced R&D CMC candidate to join our team.

Responsibilities

• Writing of technical documents required for submission to government and regulatory authorities.
• Writing of SOPs, scientific reports.
• Collect and evaluate scientific data.
• Statistical data analysis of scientific data collected at different stages of project.
• Conduct extensive literature research and studying of scientific documents.
• Act as a liaison with Regulatory Teams
• Co-ordinate with cross-functional teams to develop and execute CMC strategies for biologics development programs.
• Collaborate with internal and external stakeholders to ensure timely and successful execution of CMC activities.
• Manage CMC activities related to process development, manufacturing, analytical method development, and validation.
• Review and approve CMC-related documents, including protocols, reports, regulatory submissions, and manufacturing records.
• Ensure compliance with regulatory guidelines and standards, including FDA, EMA, and ICH guidelines.
• Identify and mitigate risks associated with CMC activities to ensure project timelines and deliverables are met.
• Provide technical advice and direction regarding adherence to regulatory standards for the manufacturing processes of biologics, analytical methodologies.

• Master's, or Ph.D. degree in Biochemistry, Biology, Biotechnology, Chemistry, or a related field.
• Minimum of 5 years of experience in development or regulatory department, with a focus on CMC.
• Understanding of biologics manufacturing processes, including cell culture, purification, and aseptic processing.
• Experience with regulatory submissions and interactions with regulatory agencies (FDA, EMA, etc.).
• Experience with statistical analysis for scientific data.
• Excellent project management skills, with the ability to interact with cross-functional teams and manage multiple projects simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Experience working in a similar role in a CMC function for Biosimilar development will be considered an asset.
• Knowledge of GMP regulations and quality systems is required.
• Excellent written and oral communication skills in English.

The company offers competitive remuneration, continuous learning and development opportunities and a friendly and challenging work environment.