Director, R&D - analytical

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

Header

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