Director, R&D - analytical

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

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.

Job description:

Role Summary

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

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility