Drug product and Formulation Development Supervisor

4 days ago

Athens, Attica, Greece Demo S.A. Full time

At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, our new Biotechnology Center in Athens, Ag. Stefanos is now fully operational.

Biotechnology is transforming healthcare, and DEMO is at the forefront with cutting-edge research and innovation. As we continue to grow, we are looking for a high-caliber Drug product and Formulation Development Supervisor to join our team.

Main duties and responsibilities:

  • Establishment of the formulation Team and Lab.
  • Lead and mentor a team of formulation scientists and analysts.
  • Manage team performance, recruitment, training, and career development.
  • Foster a culture of innovation, collaboration, and continuous improvement.
  • Design and execute formulation strategies for biosimilar products including monoclonal antibodies, fusion proteins, and other biologics.
  • Plan and oversee pre-formulation studies, stability testing, and compatibility assessments.
  • Ensure formulation designs meet bioequivalence, stability, and manufacturability criteria.
  • Manage multiple development projects, ensuring timelines, budgets, and deliverables are met.
  • Allocate resources effectively across projects and adjust plans based on priorities.
  • Collaborate with project management, regulatory affairs, and manufacturing teams.
  • Ensure all formulation activities comply with cGMP, ICH guidelines, and global regulatory requirements.
  • Review and approve technical documentation including development reports, protocols, and transfer documents.
  • Support dossier preparation and respond to regulatory queries during product registration.
  • Work closely with analytical development, process development, quality assurance, and clinical supply teams.
  • Participate in tech transfer activities to manufacturing sites.
  • Provide technical support during audits and inspections.

Requirements

  • Ph.D. or Master's in Pharmaceutics, Biotechnology, Biochemistry, or related field.
  • 8+ years of experience in biologics or biosimilar formulation development.
  • Proven leadership experience in a pharmaceutical R&D setting.
  • Strong understanding of protein chemistry, excipient compatibility, and formulation stability.
  • Familiarity with QbD principles and regulatory expectations for biosimilars.
  • Good understanding of regulations required for DP development of biotech products, preferably in biosimilars development
  • Very good knowledge of software like: Data visualization and statistics like: Graph Pad Prism, JASP, JMP or similar.
  • Strong problem-solving attitude, critical thinking
  • Resilience & ability to work independently
  • Excellent communication skills both verbal and written
  • Team player & fast learner

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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