Formulation Development

Core Formulation & Batch Execution

• Executes process evaluation, experimental, optimization, Bio/Submission batches and scale-up trials as per instructions.
• Weighs, mixes, screens and blends raw materials to produce experimental trials, pilot and small-scale batches for compressed, enteric coated, and film coated tablets, capsules, pellets, powders, liquids, and others.
• Dismantles, cleans, sanitizes and assembles formulation development rooms and equipment according to SOPs and Technical Manuals to ensure GMP compliance.
• Performs in-process quality tests on trials and batches for weight, hardness, thickness, friability, disintegration, etc.
• Delivers in-process samples to the designated area and maintains the in-process testing lab.
• Completes and signs off all process documentation required during batch execution.
• Participates in operating current Packaging equipment within specifications.
• Conducts basic troubleshooting of the entire Packaging operations.

Strategy, Research & Project Coordination

• Responsible for development and design of formulations for multiple products and conducting meetings with multidisciplinary teams.
• Conducts relevant patent searches on formulations; reviews scientific literature and makes recommendations for development strategies.
• Attends appropriate trainings, seminars, and presentations to maintain expertise in formulations.
• Communicates with buyers and peers to ensure APIs, excipients, and tooling are available in required quantities.
• Liaises with plant operation supervisors and scheduler to ensure trials and registration batches are planned and executed timely.
• Coordinates with documentation groups for early development trial documents, process evaluation and optimization documents.
• Coordinates with lab for sample requirements and provides testing timelines.
• Coordinates with documentation for timely regulatory submission of scale-up documents.

Troubleshooting & Compliance

• Recognizes out-of-normal situations and uses conventional problem-solving skills to identify root causes and troubleshoot.
• Recommends modifications to methodology where there are opportunities to improve.
• Investigates formulation/process issues, finds root causes, and plans corrective action.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrates Behaviours that exhibit organizational Values: Collaboration, Courage, Perseverance and Passion.
• Ensures personal adherence with all compliance programs including Global Business Ethics, Quality, Safety, Environment, and HR policies.

Education

Diploma or Degree in Chemistry, Pharmaceutical Technology, Engineering, or related science.

Experience

4–6 years in pharmaceutical formulation development; experience in solid oral dosage forms, scale-up, and/or technology transfer.