Drug Product and Formulation Development Supervisor

DEMO Pharmaceuticals

Athens, Greece

Description

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.