Director, Inhalation R&D & Aerosol Analytics

Xtalks; Florida; On-site; USD 150,000 - 190,000; Full time

Job summary

Xtalks is seeking a seasoned Laboratory Science Leader to manage a team responsible for characterization studies of pressurized Metered Dose Inhalers (pMDIs) and related OINDPs. The role requires deep expertise in inhalation technology, analytical chemistry, and regulatory support for CMC activities.

You will lead method development, data analysis, and cross-functional collaboration while mentoring scientists and ensuring timely project delivery across global teams.

Qualifications

• PhD in Pharmaceutics/Pharmaceutical Technology/Pharmaceutical Chemistry/Analytical Chemistry or related fields with a minimum 8 years of relevant experience; Minimum 12 years experience in pharmaceutical technology or related fields without a PhD.
• Deep knowledge of pharmaceutical and inhalation technology.
• Experience in characterization of pressurized Metered Dose Inhalers (pMDIs) and other OINDPs.
• Extensive knowledge of analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.) and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction).
• Experience in supervising 6-10 laboratory scientists.
• Experience in planning, organization and project management

Responsibilities

• Manage a group of laboratory scientists conducting standard and advanced laboratory activities.
• Independently design, conduct, lead and supervise characterization studies for pMDIs.
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as SME on aerosol analytical characterization methodologies for OINDPs.
• Lead studies for evaluation and selection of raw materials; pre-formulation, formulation and process development for pMDIs.
• Supervise analytical activities for regulatory submission including method transfer and validation of analytical methods.
• Write protocols, methods, reports, SOPs, and submission documents.
• Plan laboratory activities and resources weekly; ensure timelines.
• Develop project plans and communicate goals to the group.
• Propose and implement processes and new technologies to increase efficiencies and quality.
• Develop and implement training programs for analytical activities across sites.
• Mentor and assist junior scientists; ensure training records are maintained.
• Ensure SOP compliance and Lupin safety rules.
• Analyze data, identify trends and present to senior management; drive continuous improvement.
• Lead project activities and ensure timely delivery; communicate with teams and stakeholders.
• Troubleshoot issues and propose solutions.

Skills

Team leadership

Supervision

Inhalation technology

Project management

Data analysis

Education

PhD in Pharmaceutics/Pharmaceutical Technology/Pharmaceutical Chemistry/Analytical Chemistry or related fields

Minimum 12 years experience in pharmaceutical technology or related fields without a PhD

Tools

UPLC/HPLC

GC

UV

FTIR

Cascade Impaction

Laser Diffraction

Job description

Xtalks is seeking a seasoned Laboratory Science Leader to manage a team responsible for characterization studies of pressurized Metered Dose Inhalers (pMDIs) and related OINDPs. The role requires deep expertise in inhalation technology, analytical chemistry, and regulatory support for CMC activities.

You will lead method development, data analysis, and cross-functional collaboration while mentoring scientists and ensuring timely project delivery across global teams.