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 is a results-oriented problem-solver and laboratory analyst who will support ABC Inhalation Product Development programs. The Senior Scientist is involved in planning their own work and supervising the day-to-day activities in the laboratory working under prescribed procedures (protocols, standard operating procedures, methods, etc.). Completes work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines. Plans the conduct of a study; monitors study procedures to ensure data accuracy and report quality; conducts analysis and experimentation on substances, for such purposes as product and process development and application, quantitative and qualitative analysis and improvement of analytical methodologies. Typically serves as project leader or study director within group on complicated projects.
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.
Minimum Qualifications
• Ph.D. in Chemistry and/or related discipline (e.g. Biochemistry, Pharmaceutics) and three years 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.
Preferred Qualifications
In addition to minimum requirements listed above, will assess against preferred qualifications:
• Experience with pMDI, DPI and nasal/pulmonary delivery systems
• Direct hands-on experience desired performing inhalation techniques which include particle size distribution, dose content uniformity, fill weight, valve delivery, spray pattern, impurity and degradant analyses
• Strong skills in instrumental analysis, particularly ACI, NGI, DUSA, Microscopy, HPLC and GC
• Experience in analytical method development and validation
ABC Laboratories regrets that it is unable to sponsor employment Visas or consider individuals on time-limited Visa status for this position.
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