Formulation Scientist

About the Role

Perform formulation development, generate formulas, and scale up processes in support of ANDA or NDA submission batches in a regulated development and manufacturing environment. This role involves technical responsibility for interpreting, organizing, executing, and coordinating assignments and development projects, as well as maintaining liaison with individuals and units within or outside the organization. You will plan, organize, and supervise assigned work staff, manage product development projects, and ensure the production of clinical supplies.

Responsibilities

• Review literature and gather patent and published articles on selected projects.
• Analyze and interpret results in written and oral formats in consultation with Product Development Management.
• Determine the best strategy for formulating assigned projects to meet regulatory criteria.
• Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
• Conduct formulation experiments to develop ANDA or NDA submission batches.
• Prepare CMC documentation, project documentation, and technical reports.
• Perform processing steps such as weighing, blending, milling, and compression.
• Direct the work and schedules of technicians and provide technical assistance to associates and other formulation scientists.
• Maintain accurate lab notebooks and complete development reports in compliance with departmental needs and SOPs.
• Ensure equipment and materials are available for submission batches and coordinate with the manufacturing department as needed.
• Follow all SOPs and safety guidelines to ensure compliance with cGMP environment and safety practices.

Requirements

• Master’s degree (or higher) in a pharmaceutical science field preferred.
• Minimum of 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals.
• Technical expertise in designing pharmaceutical products and manufacturing processes.
• Proven ability to supervise technical and operational personnel.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility