Since 1968, ABC Laboratories has delivered expert scientific support to companies working to improve human and animal health. As a member of the ABC Team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Our laboratories are modern. Our instrumentation is state of the art. And our business is thriving, creating important career opportunities. More than 400 people are building their careers with ABC Laboratories. See what it’s like to do what you love and love where you live! Visit www.abclabs.com to learn more about our company and our community.
The Senior Scientist/Team Leader is a results-oriented, problem-solver and laboratory analyst 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.
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
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