Director of Inhalation R&D & Aerosol Science

Lupin Pharmaceuticals; Florida; On-site; USD 130,000 - 190,000; Full time

Job summary

Lupin Pharmaceuticals in Florida seeks a Senior Laboratory Leader to manage a team of scientists conducting standard and advanced activities for pressurized Metered Dose Inhalers (pMDIs). You will independently design studies, lead CMC activities on global project teams, and act as SME for aerosol analytical characterization.

Focus on process development, validation and regulatory submission is key. You will mentor junior scientists, plan resources weekly, and drive continuous improvement while

Qualifications

• PhD in Pharmaceutics or related field with 8+ years of relevant experience; 12+ years without PhD.
• In-depth knowledge of inhalation technology and analytical methods (UPLC/HPLC, GC, UV, FTIR).
• Experience supervising 6–10 laboratory scientists.
• Strong planning, organization and project management 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) products.
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as SME on aerosol analytical characterization methodologies for orally inhaled and nasal products (OINDPs).
• Lead characterization studies for evaluation and selection of raw materials; pre-formulation, formulation and process development studies for pMDIs following cGMP, EH&S and other relevant guidelines.
• Oversee analytical activities for regulatory submission including method transfer protocols and validation of analytical methods.
• Write protocols, methods, reports, SOPs, and submission documents; plan activities weekly and ensure timelines.
• Develop and communicate project plans, goals and strategies to the group.
• Propose and implement processes and new technologies to improve efficiency and quality.
• Develop training programs for analytical activities across sites; mentor junior scientists and conduct performance reviews.
• Ensure training compliance and SOP adherence; foster team relationships and cross-functional collaboration.
• Analyze data, identify trends and present findings to senior management.
• Lead project activities, support timelines and coordinate with internal/external customers.
• Troubleshoot issues and implement solutions.

Skills

Leadership

CMC leadership

Aerosol analytics

Project management

Mentoring

Education

PhD in Pharmaceutics / Pharmaceutical Technology / Analytical Chemistry

Job description

Lupin Pharmaceuticals in Florida seeks a Senior Laboratory Leader to manage a team of scientists conducting standard and advanced activities for pressurized Metered Dose Inhalers (pMDIs). You will independently design studies, lead CMC activities on global project teams, and act as SME for aerosol analytical characterization.

Focus on process development, validation and regulatory submission is key. You will mentor junior scientists, plan resources weekly, and drive continuous improvement while