Review and approval of technical GMP regulatory documents for submissions to USA, Europe, Asia, and Australia. Responsible for preparing and presenting metrics of regulatory compliance. Responsible for ensuring GMP documents and investigations are performed in alignment with current regulator requirements.

• Review and final approval of technical laboratory operations including method validation, method transfer, in-process manufacturing support, stability testing, and maintaining compliance with cGMP procedures. • Responsible for developing a robust training program for techniques in both the analytical and biochemistry group. Trained all the senior personnel in the Quality Control group for laboratory tours for clients, internal audits, and regulatory audits.• Responsible for developing a system to log in and track the use of critical reagents and reference material.• Responsible for scheduling and completion of all Quality Control testing in support of the manufacturing facility for Biochemistry and Analytical testing.• Responsibility for group’s deliverables and budget performance and planning. Prepare for and contribute to budget planning for the quality control department. • Responsible for managing a group of 20 analysts and two senior scientist and overseeing their respective career growth and opportunities.

• Review and final approval of technical laboratory operations including method validation, method transfer, in-process manufacturing support, stability testing, and maintaining compliance with cGMP procedures. • Responsible for developing a robust training program for techniques in both the analytical and biochemistry group. Trained all the senior personnel in the Quality Control group for laboratory tours for clients, internal audits, and regulatory audits.• Responsible for developing a system to log in and track the use of critical reagents and reference material.• Responsible for scheduling and completion of all Quality Control testing in support of the manufacturing facility for Biochemistry and Analytical testing.• Responsible for managing a group of 20 analysts and two senior scientist and overseeing their respective career growth and opportunities.

• • Review and final approval of technical laboratory operations including method validation, method transfer, product characterization, stability testing, chromatographic trouble shooting, and maintaining compliance with cGMP procedures.• Responsible for technical operations of full scale development programs ranging from pre-IND to Ph IV, including pre-formulation work, process development, manufacturing cleaning verification, analytical method development and validation. • Responsible for negotiating service contract with multiple vendors, scheduling service calls, and troubleshooting instrument issues.• Responsible for transferring materials for multiple customers between internal departments and external sites. Maintenance of proper documentation of control drugs in accordance with Federal guidelines.• Responsibility for group’s deliverables and budget performance and planning. Prepare for and contribute to budget planning for the inhalation department. • Technical writing including analytical reports, test protocols, analytical test methods, and Standard Operating Procedures (SOPs).• Coordination of cross functional teams on onboarding of instruments and software projects within budget and on time.• Project management including oversight of project budgets, schedules, performance requirements, primary customer contact, and regulatory guidance on multiple projects.• Completion of more than 95% of all projects within timed resources and budget• Supervisor of junior scientists, including training, mentoring, scheduling, and performance reviews. Access training needs and formulate development plans for subordinates.• Supervising a technical scientific team of up to 15 chemists and overseeing their respective career growth.

Responsible for stability and release testing of inhalation drugs for the pulmonary and nasal department. Responsible for managing vendor visits and negotiation of vendor contract.