- 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