Sanaria is currently expanding its activities and is accepting inquiries and resumes for the positions listed below. If you are interested in furthering your career with us please send the following information to firstname.lastname@example.org:
Sanaria is an equal opportunity employer.
AVAILABLE POSITIONS: Senior Research Associate or Research Associate Research Associate Immunology Senior Quality Assurance Specialist Document Control Specialist Clinical Research Associate Medical Writer
Senior Research Associate or Research Associate
Sanaria manufactures a malaria vaccine using aseptic mosquitoes as a bioreactor. We are developing a novel method for the manufacture malaria vaccine in vitro without the need for mosquitoes. The Associate will join the Mosquito Production and In vitro Sporozoite Production Team and will contribute to the exciting ongoing research programs including optimizing production of Plasmodium sporozoites without the use of mosquitoes and improving the sporogonic development of Plasmodium in mosquitoes.to optimize and improve the production methodology. The Associate will also work on GMP manufacture of aseptic mosquitoes as well as PfSPZ Vaccine, develop methodologies and conduct experiments to further improve vaccine production, participate in aseptic mosquito production, revise and develop SOPs and batch records for aseptic mosquito production and vaccine manufacture, review batch records, monitor sporogonic development of malaria parasites in mosquitoes, transfer aseptic mosquitoes for vaccine manufacture etc.
Qualified candidates must have an M.S. or B.S. in Biology/Entomology or a related discipline with 1-4 years' relevant experience in tissue culture, 3D culture methodology or malaria parasite sporogonic development. Experience that includes sterile technique, Plasmodium biology, microscopy, mosquito genetics and cell biology is preferred. Experience in GMP manufacturing a plus. Attention to detail, excellent communication, writing, team work and organization skills and the willingness to learn new experimental and operational techniques are essential. U.S. citizenship or permanent eligibility to work in the U.S. is required.
Research Associate Immunology
The Research Associate will be involved with the malaria PfSPZ vaccine Production and Research endeavors at Sanaria. This position primarily involves participation in activities related to extraction and quantification of the sporozoite stage of the malaria parasite and characterization of the parasite's biological attributes in cell culture assays and experimental models. The incumbent is also expected to participate in research projects designed to test the immunogenicity of vaccine formulations.
Qualified candidates must have a Master's Degree in Biology or a related discipline, or a Bachelor's degree with 3-5 years of experience in one or more of the following: malaria, cell culture, bio-engineering, immunology, GMP manufacturing. Excellent communication, writing, team work and organization skills and the willingness to learn new experimental techniques in a highly collaborative environment are required. Ability to write up technical reports, summaries, protocols and quantitative analyses, and proficiency in 'Microsoft excel' and 'Microsoft word' is a must. Experience with sterile technique, microscopy and tissue culture is desirable.
Senior Quality Assurance Specialist
The position will be responsible for further developing and maintaining the quality system and developing quality assurance policies, programs and procedures for the company's clinical product, a novel malaria vaccine. This position will be responsible for defining processes or improving processes for receiving, manufacturing, packaging, testing and distribution for the clinical vaccine.
Clinical Research Associate
The Clinical Research Associate will support Sanaria's clinical research program under the direction of senior members of the Clinical Department, working on both departmental and individual study assignments. This position will support compliance with Good Clinical Practices and with the Code of Federal Regulations in Sanaria's clinical trials, from pre-initiation through closeout, and from phase 1 to vaccine licensure.
Duties will include helping to: organize and conduct sponsor/site teleconferences; assist with IRB document submission; assist with the retrieval, tracking and maintenance of clinical study documents in Sanaria's electronic Trial Master File (eTMF); and ensure that all study documents are in place at the start of trials and collected at the close of trials. The Clinical Research Associate will review clinical documents (e.g. protocols, consent forms, study templates, SOPs, case report forms, etc.), help to develop and write SOPs for the Clinical Department, maintain and support Veeva Vault eTMF software, perform validation, and provide training to company and study site staff. The Clinical Research Associate will assist with reviewing monitoring plans, organizing Safety Monitoring Committees, planning and conducting site investigator meetings, and reviewing progress reports and safety reports to ensure accuracy, scientific excellence and timely submission. The CRA will liaise with the data management vendor to resolve database issues.
Qualified Candidates will have a BA/BS degree in a health or science field (Masters degree preferred), 3-5 years of experience with clinical trials (malaria trials and international sites preferred), and Good Clinical Practices certification. The successful candidate will be mission-driven, exhibit high professional standards, communicate effectively and contribute to a dynamic, collaborative team environment. Independent international travel is required.
Sanaria is now embarking on an ambitious program designed to lead to licensure, and will be conducting clinical trials at multiple sites in Africa, Europe, and the United States. Sanaria is currently recruiting for a Medical Writer experienced with Clinical Protocols, Amendments, Reports, and Manuscripts, ideally with background in vaccine (or drug) development.
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