Under the general guidance of Director, the incumbent provides technical leadership in designing and conducting scientific experiments for process development, optimization, scale-up and technology transfer activities leading to the attainment of short and long-range Merial objectives. Provides a lead role as technical liaison with multidisciplinary R&D groups and global manufacturing sites. As a senior staff member, the incumbent supervises other scientists providing mentoring and technical and administrative guidance and assigns responsibilities in managing multiple projects.
Major responsibilities include:
• Provide technical support and guidance in designing and performing simple to complex experimental studies to identify and optimize critical process parameters and define their optimal ranges for the development of robust manufacturing processes for novel and line extension veterinary pharmaceutical products.
• Develop creative approaches and solutions and applies these to assigned projects as well as to develop new platform technologies and improve existing processes.
• Coordinate with others in arranging and scheduling activities for the pilot area and for tracking development projects and allocating resources.
• Represent the department on multi-disciplinary teams and demonstrates a solid knowledge of current regulatory guidelines and advanced technical knowledge.
• Document and prepare comprehensive, accurate and well written reports and project summaries.
• Lead, train and mentor other senior and/or junior scientists as assigned.
• Interact routinely and effectively with external areas e.g. Manufacturing, QA, Formulation Development, and Analytical.
• Conduct work which meets high standards of technical rigor, quality, safety and cGMP compliance and manages multiple projects.
• Bachelor's Degree in Pharmacy, Chemical Engineering or related field with minimum of 8 years or MS with minimum of 6 years or Ph.D. with more than 3 years of applicable experience in the pharmaceutical industry.
• Must have demonstrated ability in formulation/process development, scale-up, clinical manufacturing and technology transfer activities for pharmaceutical products such as solids oral, liquid, topical and parenteral dosage forms.
• Demonstrated knowledge of process validation.
• Working knowledge of cGMPs.
• Excellent interpersonal, written and oral communication skills are necessary and supervisory ability is desirable.
State or Province