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Job Description
Primary Job Purpose:
Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.
Position Summary
• Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects.
• Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management.
• Plans, organizes and supervises the assigned work staff of associates and technicians.
• Responsible for project management of assigned product development projects.
• Responsible for the production of clinical supplies.
Duties and Responsibilities
• Review Literature and gather patent and published articles on the selected projects.
• Analyze and interpret results in written and oral format in consultation with Product Development Management.
• Determine best possible strategy for formulating assigned projects and meet regulatory criteria.
• Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
• Perform formulation experiments to develop ANDA or NDA submission batches.
• Responsible for CMC documentation, project documentation and for preparing necessary technical reports.
• Perform all the processing steps such as weighing, blending, milling, compression etc.
• Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists.
• Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs.
• Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.
Qualification and Experience
Master's degree (or higher) in a pharmaceutical science field preferred.
Minimum 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals.
Technical expertise necessary to design 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
