Director, Inhalation Formulation R&D

Lupin; Florida; On-site; USD 190,000 - 230,000; Full time

Job summary

Lupin seeks a Director of Formulation R&D to lead a laboratory team focused on pMDI development and aerosol analytics. The role designs and supervises advanced studies, guides CMC activities, and ensures regulatory readiness in collaboration with global project teams.

The candidate will supervise 6–10 scientists, drive process improvements, and mentor staff while advancing pre-formulation, formulation, and process development for pMDIs under cGMP and Lupin guidelines.

Qualifications

• PhD in Pharmaceutics/Pharmaceutical Chemistry or related field with 8+ years of relevant experience; 12+ years without PhD.
• Deep knowledge of inhalation technology and pMDI characterization.
• Experience supervising 6–10 laboratory scientists.
• Strong project management and planning skills.

Responsibilities

• Manage a group of laboratory scientists conducting standard and advanced laboratory activities.
• Independently design, conduct, lead and supervise characterization studies for pressurized Metered Dose Inhalers (pMDIs).
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as SME on aerosol analytical characterization methodologies for OINDPs.
• Lead material evaluation and development studies for pMDIs following cGMP, EH&S and other guidelines.
• Oversee analytical work for regulatory submissions including method transfer and validation.
• Write protocols, methods, reports, SOPs, and submission documents.
• Plan laboratory activities and resources to meet project timelines.
• Develop project plans and strategies for the group.
• Drive process improvement and training programs across sites.
• Mentor junior scientists and manage training records.
• Communicate with internal/external customers and other groups.
• Troubleshoot issues and implement improvements.

Skills

Pharmaceutical tech

Inhalation tech

Analytical chemistry

Aerosol characterization

Team leadership

Project management

Education

PhD in Pharmaceutics/Pharmaceutical Technology/Pharmaceutical Chemistry/Analytical Chemistry

Tools

UPLC/HPLC

GC

UV

FTIR

Job description

Lupin seeks a Director of Formulation R&D to lead a laboratory team focused on pMDI development and aerosol analytics. The role designs and supervises advanced studies, guides CMC activities, and ensures regulatory readiness in collaboration with global project teams.

The candidate will supervise 6–10 scientists, drive process improvements, and mentor staff while advancing pre-formulation, formulation, and process development for pMDIs under cGMP and Lupin guidelines.