Role & responsibilities

Formulation Development
Lead development of lyophilized injectable formulations from pre-formulation to commercial scale.
Design and optimize formulations and freeze-drying cycles.
Conduct formulation feasibility studies, stability studies, and process optimization.
Develop robust and scalable manufacturing processes.

Technical Leadership
Provide scientific and technical guidance to formulation development teams.
Review experimental protocols, technical reports, and development documentation.
Troubleshoot formulation and process-related challenges.

Technology Transfer & Scale-up
Lead pilot, exhibit, and validation batch activities.
Coordinate technology transfer to manufacturing sites.
Support process validation and commercial manufacturing readiness.

Regulatory & Compliance
Prepare and review CMC documentation for regulatory submissions.
Support responses to regulatory agency queries.




Ensure compliance with cGMP, ICH, USFDA, EMA, and other applicable regulatory requirements.

Cross-Functional Collaboration
Collaborate with Analytical Development, Manufacturing, QA, QC, Regulatory Affairs, and Project Management teams.
Drive project timelines and achieve development milestones.

Team Management
Lead, mentor, and develop a team of formulation scientists.
Manage project prioritization, resource allocation, and team performance.

Preferred candidate profile
1218 years of experience in pharmaceutical formulation development.
Minimum 57 years in a leadership or managerial role.
Robust experience in:
Lyophilized injectable products
Sterile formulation development
Technology transfer and scale-up
Regulatory submissions for global markets

📌 Senior Manager Formulation Development Lyophilized Injectables Ahmedabad
🏢 Intas
📍 Ahmedabad