Senior Formulation Development Manager

hace 13 horas

Barcelona, España Ferrer A tiempo completo

Senior Formulation Development Manager Join to apply for the Senior Formulation Development Manager role at Ferrer. Mission The Senior Formulation Development Manager will lead and manage all formulation and process development activities within the Pharmaceutical Development Department. They will lead a team of Senior Scientists in the formulation development of new products (New Chemical Entities) and reformulation of products already marketed. Responsibilities Lead, coordinate and manage a team of five scientists and technicians to carry out drug development activities from pre‑formulation through scale‑up to the industrial plant. Apply hands‑on scientific and technical knowledge to excipients, formulation and manufacturing processes for identification of critical material attributes (CMAs) and critical process parameters (CPPs). Ensure activities follow ICH Q8, Q9, Q10, internal SOPs, GxP, and health and safety requirements. Generate sufficient data for regulatory filings (NDA/ANDA) in the USA, EU and other jurisdictions; write or review formulation and manufacturing sections for filings. Ensure pilot plant facilities and equipment are qualified, calibrated and safe; ensure staff is trained and updated. Control the schedule and planning of formulation development activities, allocating resources effectively and meeting deadlines. Collaborate closely with the Analytical Development Team on key aspects of pharmaceutical development. Supervise and collaborate with other company departments to ensure correct project progress. Qualifications Background and experience: MS/PhD in Pharmaceutical Sciences or equivalent. At least 15 years of experience in formulation development from early development to late scale. At least 7 years of leadership experience in formulation departments or larger teams, including recruiting and coaching high‑performing teams. Proven leadership ability and innovation skills. Strong background in solid oral dosage forms, liquid formulations (solutions and suspensions), injectables, poorly soluble compounds and modified release technologies. Working understanding of GMP and regulatory guidelines applicable to product development. Experience with EMA and other regulatory agencies in regulatory filings, deficiencies letters and clarifications. Skills and competencies: Ability to manage multiple projects simultaneously. Strong verbal and written communication skills. Teamwork and collaboration. Capability to work in a dynamic environment with flexibility and adaptability. Efficiency and optimization mindset. Highly motivated, creative and curious scientist interested in new technologies and innovation. EEO Statement At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience. #J-18808-Ljbffr

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