Director, R&D - analytical

Lupin•Coral Springs, FL, FL

12d

About The Position

The Director, R&D - analytical manages a team of laboratory scientists conducting standard and advanced laboratory activities. The role independently designs, conducts, leads, and supervises characterization studies for pressurized Metered Dose Inhaler (pMDI) products, and provides leadership in CMC activities, including representing CMC on global project teams. The position serves as a subject matter expert in aerosol analytical characterization methodologies for orally inhaled and nasal products (OINDPs). The role leads characterization work to evaluate and select raw materials, including APIs, excipients, packaging materials, and device component materials, and supports pre-formulation, formulation, and process development studies for pMDIs. It supervises analytical activities for regulatory submissions, including method transfer protocols and analytical method validation, and prepares protocols, methods, reports, standard operating procedures, and submission documents as needed. The work must follow cGMP, Lupin EH&S requirements, and relevant Lupin, FDA, and other governing-body guidelines. The Director plans laboratory activities and resources, manages project progress and timelines, communicates project plans and strategies, and drives process improvement and the adoption of technologies that improve efficiency and quality. The position develops and implements training programs across respiratory development sites, mentors junior scientists, oversees staff training records and performance reviews, and supports team members’ development. It also analyzes data and trends, performs statistical analysis, presents recommendations and conclusions to senior management, troubleshoots technical issues, and collaborates with internal and external stakeholders.

Requirements

PhD in Pharmaceutics, Pharmaceutical Technology, Pharmaceutical Chemistry, Analytical Chemistry, or a related field, with at least 8 years of relevant experience; alternatively, at least 12 years of experience in pharmaceutical technology or related fields without a PhD.
In-depth knowledge of pharmaceutical and inhalation technology.
Relevant experience characterizing pMDI products and other OINDPs.
Extensive knowledge of analytical chemistry methodologies, including UPLC/HPLC, GC, UV, and FTIR.
Knowledge of aerosol characterization methodologies, including cascade impaction and laser diffraction techniques.
Experience 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 pMDI products.
Provide leadership in CMC activities and represent CMC on global project teams.
Serve as a subject matter expert in aerosol analytical characterization methodologies for OINDPs.
Lead characterization studies to evaluate and select raw materials and support pMDI pre-formulation, formulation, and process development.
Supervise and lead analytical activities required for regulatory submissions, including method transfer protocols and analytical method validation; participate in laboratory activities as required.
Write protocols, methods, reports, standard operating procedures, and submission documents as needed.
Plan laboratory activities and resources, manage project progress, and ensure project timelines are met.
Develop and communicate project plans, goals, and strategies to the group.
Propose and implement processes and technologies that improve the efficiency and quality of laboratory activities, and drive continuous improvement.
Develop and implement training programs for analytical activities across respiratory development sites.
Mentor and assist junior scientists; ensure group members are trained on relevant methods, policies, and procedures.
Verify that group members’ training records are updated at least twice a year, conduct quarterly performance reviews, provide regular feedback, and support staff development.
Influence team decisions and establish and maintain effective relationships with team members.
Ensure laboratory work follows SOPs and Lupin safety rules and procedures, and comply with Lupin corporate guidelines and policies.
Analyze data, identify trends, perform statistical analyses, and regularly present data, recommendations, and conclusions to senior management.
Lead project activities, support project timelines, and contribute to team objectives.
Communicate effectively with team members, internal and external customers, and other functional groups.
Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.