Scientist II, Pharmaceutical Chemistry and Formulation Development
Durham (United States of America) | Washington D.C.
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Scientist II, Pharmaceutical Chemistry and Formulation Development
Initiates, directs, and executes all scientific research and/or development strategies in research studies and scientific projects or the provision of research-support services. Investigates the feasibility of applying a wide variety of scientific principles, methods, and concepts to studies, problems, and projects. Plans and executes training/training materials for research studies and internal and external researchers. Makes major contributions to scientific literature and conferences. Acts as spokesperson on corporate research studies and scientific projects and advises executive management. Interfaces with various departments and serves as an internal consultant.
Job Summary / Responsibilities:
- Provides technical and scientific leadership in product development activities, product problem solving, protocol development and report writing.
- Leads and participates in investigations to drive technically and scientifically sound corrective and preventative actions including critical review of SOP and process documents.
- Oversees product support laboratories to insure development and investigative work is done effectively and efficiently.
- Write, review, and approve protocols, papers, research strategies, proposals, batch records, procedures, specifications, and test methods for methodological and technological soundness.
- Provides scientific support with implementing, conducting, and managing research studies and proposals.
- Collaborates with higher level scientists on various research materials, statistical results, and medical/clinical agendas.
- Leads the successful design, implementation, and analysis of peer–reviewed research activities.
- Develops and improves systems, including manuals or documents that strengthen services and technical assistance efforts.
- Represents leadership by speaking, organizing or leading national or international conferences, serves on scientific or technical advisory boards, and gives oral presentations or teaches university course level work.
- Mentors and guides other scientists through collaboration of research strategies, processes, and findings.
Applied Knowledge & Skills:
- Deep and thorough understanding of chemical and material science, engineering and development of pharmaceutical dosage forms with focus on the impact of physicochemical properties on dosage form development.
- Experience with the identification, development, and implementation of novel chemical engineering technologies to drug delivery systems, specifically non-oral sustained release formulations
- Knowledge of requirements for development of drug product formulation; development and implementation of manufacturing process; and development and transfer of analytical methods.
- Experience in working closely with, product development, pre-clinical, and clinical scientists to generate and interpret data to provide enhanced understanding and guidance for formulation development.
- Excellent communication, organization, and planning skills and a high level of technical aptitude and creativity
- Ability to provide cross-functional leadership and guidance to CMC and non-clinical teams.
- Ability to work with various partners in an outsourcing model
- Proven track record in identification and optimization of safe, scalable dosage forms that focus on product quality
- Demonstrated proficiency and knowledge of cGMPs, ICH and other worldwide regulatory expectations; experience with US FDA or EU regulatory submissions preferred
- Ability to analyze and interpret data, identify errors and provide correction action.
- Project or technical leadership experience required.
- Works on problems that are diverse and complex requiring analysis or interpretation of factors or situation.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions have major impact on the management and operations of an area within a department.
- Serves as the mentor/team lead to other scientists.
- Doctorate Degree or its International Equivalent in Chemistry, Chemical Engineering, Materials Science, or related physical science with 8+ years relevant experience OR Master’s Degree in Chemistry, Materials Science, or related physical science with 11+ years relevant experience.
- Typically requires 5+ years of experience in pharmaceutical development.
- Formulation development from pre-clinical formulation proof-of-concept to early phase clinical.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- Must be able to read, write, and speak fluent English.
Or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360's Career Center for a list of all open positions.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is committed to providing equal employment opportunity without regard to race, color, religion, sex, gender identity, sexual orientation, national or ethnic origin, age, disability or status as a veteran with respect to policies, programs, or activities.
- Organization: FHI 360 - Family Health International
- Location: Durham (United States of America) | Washington D.C.
- Grade: Mid/Senior - Internationally recruited position - Mid/Senior level
- Biology and Chemistry
- Public Health and Health Service
- Project and Programme Management
- Scientist and Researcher
- Closing Date: 2015-11-30