Formulation And Development Manager

Role & responsibilities

1. Formulation Development

• Design and develop sterile formulations including liquid injectables (SVP/LVP), lyophilized products, and ophthalmic solutions/suspensions.
  • Selection and optimization of excipients (buffers, stabilizers, tonicity agents), solvent systems, pH, osmolality, and viscosity.• Conduct pre-formulation studies including solubility, compatibility, and stability studies.

2. Process Development & Scale-up

• Develop robust and scalable manufacturing processes including compounding, sterile filtration, aseptic filling, and lyophilization cycle development.
  • Support scale-up, pilot batches, and exhibit batches.• Ensure smooth technology transfer to manufacturing sites.

3. Regulatory & Compliance

• Prepare and review regulatory documentation including Module 3 (CTD), development reports, and process justifications.
  • Support ANDA / NDA / MAA submissions and respond to regulatory queries.• Ensure compliance with cGMP, ICH guidelines, and USFDA / EMA / WHO requirements.

4. Stability & Validation

• Design and monitor ICH stability studies (accelerated and long-term).
  • Support process validation, media fill studies, and cleaning validation.• Investigate and resolve OOS, OOT, and deviations related to formulations.

5. Team Leadership & Project Management

• Lead and mentor formulation scientists and executives.
  • Plan and track project timelines, milestones, and deliverables.• Coordinate with Analytical R&D, QA/QC, Manufacturing, and Regulatory Affairs.• Drive continuous improvement and cost optimization.

6. Troubleshooting & Lifecycle Management

• Provide technical support during commercial manufacturing and scale-up challenges.
  • Support investigation of market complaints.• Implement post-approval changes, reformulation, and optimization.

Preferred candidate profile

Technical Skills:
• Expertise in aseptic processing, lyophilization science, and sterility assurance.• Knowledge of container closure systems (vials, ampoules, PFS), elastomer compatibility, and extractables & leachables.• Familiarity with PAT, QbD, and DoE is preferred.Behavioral & Managerial Skills:• Strong leadership and mentoring ability.• Excellent problem-solving and analytical skills.• Cross-functional collaboration and strong documentation mindset.