Formulation & Development (OSD) - Manager

Role Purpose

Responsible for managing formulation development activities of Oral Solid Dosage (OSD) forms including Tablets, Capsules, DC Granules, and related dosage formats, ensuring development from concept to commercialization in compliance with regulatory and GMP requirements.

Key Responsibilities

Formulation Development

• Lead design and development of robust OSD formulations for regulated and semi-regulated markets.
  
• Conduct pre-formulation studies, API characterization, excipient compatibility & selection.
  
• Design QbD-based formulation studies, DoE trials, and scale-up plans.
  
• Preparation & review of BMR, BPR, MFR, BOM, and process development documentation.
  
• Execute pilot batch, exhibit (PV/PPQ), and commercial transfer batches.
  
• Evaluate and optimize tablet & capsule processes granulation, compression, coating, encapsulation.
  

Process Development

• Conduct trials in F&D pilot plant and evaluate manufacturing feasibility.
  
• Establish scale-up parameters (Lab Pilot Commercial).
  
• Troubleshoot formulation & manufacturing issues at plant.
  

Documentation & Compliance

• Prepare product development reports (PDR), technical documents, and validation protocols.
  
• Review regulatory documents including ANDA, Dossiers, CTD modules.
  
• Support QA in responding to customer & regulatory queries.
  

Analytical Coordination

• Coordinate with Analytical R&D for method development and specification finalization.
  
• Evaluate stability data and finalize shelf life.
  

Regulatory Knowledge

Preferred experience in:

• US/EU filing requirements
  
• CTD module preparation
  
• QbD approach, risk assessment, and DoE
  
• Technology transfer documentation
  

Team Management

• Manage a team of formulation scientists, executives and technicians.
  
• Provide training, competency development, and project allocation.
  
• Lead project review and progress meetings.
  

Stakeholder Management

• Liaise with QA, QC, Engineering, Production & Procurement teams.
  
• Vendor interaction for API, excipients, packaging materials.
  

Key Skills

• Strong knowledge of pharmaceutical formulation principles.
  
• Expertise in compression, coating, dissolution & stability evaluation.
  
• Knowledge of PAT, QbD, DoE & scaling concepts.
  
• Strong documentation and report writing skills.
  
• Exposure to regulatory audits.
  

Qualification

• PhD / M. Pharm / (Preferably Pharmaceutics)
  

Experience

• 1015 years of experience in OSD formulation development.
  
• Experience in regulated market development preferred.
  

Behavioral Competencies

• Analytical mindset & result orientation
  
• People leadership & team mentoring
  
• Strong communication & decision-making skills
  
• Ability to handle multiple complex projects