ABC Laboratories, Columbia, MO. The Senior Scientist / Team Leader is a results-oriented, problem-solver and laboratory supervisor who will support ABC Inhalation Product Development programs. Experience with pMDI, DPI and nasal/pulmonary delivery systems is required. Direct hands-on experience desired performing inhalation techniques which include but are not limited to, Particle Size Distribution, Dose Content Uniformity, Fill weight, Valve Delivery, Spray Pattern, Impurity and degradation products. Strong skills in instrumental analysis, particularly ACI, NGI, DUSA, Microscopy, HPLC, and GC, general sample preparation and data interpretation desired. Experience in analytical method development and validation also a plus. Individual must be highly organized, have a strong work ethic and be able to meet project deadlines with minimal direct supervision.
Job Duties and Responsibilities:
• Designs, carries out and performs complex experiments and procedures in accordance with all applicable regulatory (i.e. FDA, DEA, etc) requirements as defined by protocol, method and standard operating procedures. Performs progressively more complex procedures and experiments.
• May utilize equipment, facilities and personnel to produce sound scientific results in a timely fashion for ABC Laboratories’ clients.
• Serves as point of contact for both internal and external contact with permission from Program Manager.
• Adheres to a schedule according to facility or contracting organization’s timetable and establishes daily or weekly work routines necessary to ensure on time delivery.
• Designs and conducts most procedures independently using laboratory equipment, computer resources and institutional libraries.
• Trains staff on techniques necessary to perform laboratory assignments.
• Performs data analysis, first level and peer review of data for accuracy and completeness. Prepares data and reports of completed projects ensuring auditable quality for publication at completion of contracted work by clients.
• Responsible for the quality and accuracy of the data and reports sent to client under assigned responsibility.
• May serve as Study Director, Principal Investigator or Project Leader for GLP and CGMP studies.
• May work on several projects concurrently and may monitor and direct activities of other staff performing work in area of expertise.
• Conducts studies to determine and deliver results involving the composition, structure, properties, relationships and all critical parameters of the material contracted for testing.
• May confer with other scientists and engineers regarding research and be required to prepare technical papers and reports.
• Prepares standards and specifications for processes, facilities, products and tests.
• Performs other related duties as required and directed.
Education and Experience:
• Ph.D. in Chemistry and/or related discipline (e.g. Biochemistry, Pharmaceutics) and three scientific experience.
• Master’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Pharmaceutics) and six years scientific experience.
• Bachelor’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Pharmaceutics) and ten years scientific experience.
Specialized Knowledge, Skills or Training:
• Previous experience with CGMP, CGLP, EU, JP, and ICH guidelines
• Andersen Cascade Impactor (ACI)
• Next Generation Impactor (NGI)
• Marple Miller Impactor
• Malvern Spraytec
• Content Uniformity
• Emitted Dose
• Spray Pattern
• Plume Geometry
• HPLC
• Pressurized Metered Dose Inahaler (pMDI)
• Dry Powder Inhaler (DPI)
• Nasal solution/suspension inhalers
• Nebulized solution/suspensions
