Director, R&D - analytical

Lupin; Florida; Híbrido; USD 170.000 - 230.000; Jornada completa

Descripción de la vacante

Lupin is seeking a senior leader to manage a team of laboratory scientists focused on standard and advanced lab activities for pressurized Metered Dose Inhalers (pMDIs). The role requires directing characterization studies, providing CMC leadership on global projects, and acting as SME for aerosol analytics in inhalation products.

The candidate will supervise 6–10 scientists, develop training programs, and ensure regulatory submission readiness with validated analytical methods, while driving

Formación

• PhD in relevant fields with a minimum 8 years of experience; or 12+ years of experience in pharma tech without a PhD.
• Extensive knowledge of inhalation technology and pMDI characterization.
• Experience supervising 6–10 laboratory scientists.
• Strong expertise in analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR) and aerosol characterization techniques.

Responsabilidades

• Manage a group of laboratory scientists conducting standard and advanced laboratory activities.
• Independently design, conduct, lead and supervise characterization studies for pMDIs and related products.
• 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; oversee pre-formulation and formulation studies.
• Supervise analytical activities for regulatory submissions including method transfer and validation.
• Plan weekly laboratory activities, ensure timelines, and communicate project plans to the group.
• Mentor and train junior scientists; conduct quarterly performance reviews.

Conocimientos

Leadership

CMC leadership

Aerosol characterization

Analytical chemistry methods

People management

Educación

PhD in Pharmaceutics/Pharmaceutical Chemistry/Analytical Chemistry

Herramientas

Cascade Impaction

Laser Diffraction

UPLC/HPLC

GC/UV/FTIR

Descripción del empleo

Manages a team of laboratory scientists conducting standard and advanced laboratory activities. Independently designs, conducts, leads and supervises characterization studies for pressurized Metered Dose Inhalers (pMDIs) products. Supports evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for pMDIs following cGMP, Lupin EH&S and other relevant guidelines. Leads the development and evaluation of new aerosol analytical technologies where required. Initiates investigations and data reviews. Manages resources and assure progress of project activities on a daily basis. Coaches, mentors and trains team members.

Essential Duties and 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 subject matter expert (SME) on aerosol analytical characterization methodologies for orally inhaled and nasal products (OINDPs).

Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for pMDIs following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.

Supervise and lead the execution of analytical activities required for regulatory submission including method transfer protocols and validation of analytical methods. Participate in laboratory activities as required.

Write protocols, methods, reports, standard operation procedures, and submission documents when required. Plan laboratory activities and resources on a weekly basis and ensure that project timelines are met consistently.

Develop and communicate project plans, goals and strategies to the group.

Propose and implement processes and new technologies that lead to increased efficiencies and quality of laboratory activities. Drive the continuous improvement process.

Develop and implement appropriate training programs for analytical activities across all respiratory development sites.

Mentor and assist junior scientists.

Ensure that members of the group are trained on relevant methods, policies and procedures. Verify that training records of group members are updated at least twice a year. Conduct quarterly performance reviews of group members and provide them with regular feedback. Support the personal development of group members.

Influence decisions within team.

Establish and maintain effective relationships with team members.

Ensure lab work is conducted in accordance with SOPs; follow Lupin safety rules and procedures.

Comply with all Lupin Corporate guidelines and policies.

Analyze data, identify trends and perform statistical analysis. Present data, recommendations and conclusions to senior management on a regular basis.

Lead project activities, support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups.

Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.

Qualification and Experience

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.

In depth knowledge of pharmaceutical and inhalation technology.

Relevant experience in characterization of pressurized Metered Dose Inhalers (pMDIs) products and other OINDPs.

Extensive knowledge of analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.) and aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.).

Experience in supervising 6-10 laboratory scientists.

Experience in planning, organization and project management