Formulation & Process Development Scientist

Area of responsibility 1: Development of new pharmaceutical products or optimization of existing pharmaceutical products (R&D roadmap)

• Lead and manage the development of new drug delivery methods for animals, including creating novel dosage forms and manufacturing processes for both internal and outsourced projects.
• Create detailed formulation development plans to help establish and meet project timelines.
• Spearhead the use of Quality by Design (QbD) and Design of Experiments (DOE) to develop products and processes, ensuring product quality by controlling critical factors.
• Collaborate with the global product development team to prepare, execute, and evaluate the stability of various dosage forms, more specifically solids like tablets and chews, as well as powders and liquids, at lab, pilot, and industrial scales.
• Identify and resolve issues in manufacturing processes and recommend improvements.
• Write and approve key documentation, including manufacturing protocols, Master Batch Records, change controls, deviations, and technology transfer reports, for all scale-up or production batches.
• Mentor and guide product development technicians in data collection and analysis.
• Compile and analyze stability data.
• Draft product specifications and organize documentation for the Dossier, collaborating with the analytical and CMC teams.
• Collaborate closely with manufacturing and operations to monitor production and transfer new products to industrial production.
• Ensure timely communication about project status, results, and formula/process development to all relevant technical and project teams i.e. Analytical, tech. Reg., QA, API, MSAT, IO.
• Engage in continuous learning by attending industry expos and conferences, applying acquired knowledge.
• Maintain compliance with cGMP, GLP, GCP, FDA, and EMA guidelines whenever applicable.
• Address questions from regulatory authorities and support quality audits.

Area of responsibility 2: Ensure (maintain/improve) laboratory compliance to GMP/GDP/GCP practices, internal SOPs and safety

• Ensure data integrity and compliance to company SOPs/policies and specifications, FDA and EMA cGMP regulations, and Virbac safety policy.
• Adequately maintain a working knowledge of appropriate scientific instrumentation, equipment, and methodologies in manufacturing, packaging and physico-chemical characterization.
• Adequately adhere to overall good documentation practices (GDP).
• Identify and support initiation of Deviations, CAPAs and Investigations.

Requirements (Diploma and experience)

• BS Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree
• 3+ years of experience in the pharmaceutical-related field.

Skills

• Mastery of skills in formulation science and/or process development, project management, in a GMP/GLP environment, either within Virbac or at a previous employer.