Sanaria
Sanaria

Employment

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 careers@sanaria.com:

  • Cover letter
  • Resume or CV
  • Salary requirements

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.

Responsibilities

  • Responsible of daily QA activities and related cGMP compliance
  • Manage deviations, investigations, OOS and CAPA
  • Raw data review for GXP reporting
  • Change Control Management
  • Internal audits and external vendor Audit
  • Perform GXP training
  • Supplier Quality Management
  • Clinical Product release and COA generation
  • Work directly with the Senior Management to assure both continuous improvement of the Quality System and provide leadership for the overall Quality Management system.

Qualifications

  • In depth knowledge of US and EU GMP's
  • In depth knowledge of USP and EP compendium
  • In depth knowledge of aseptic and sterile product quality
  • Prior involvement in establishing quality systems and experience in biologics/vaccines are preferred
  • Strong communication, project management, leadership skills and excellent written and oral English language skills are essential/li>
  • The ability to work in a fast paced environment with multiple and competing priorities is essential
  • Bachelor's degree in a science-related field, required; MS or Ph.D. preferred
  • At least 10 years of experience in the pharmaceutical/medical device/diagnostic industry including at least 5 years or progressive management experience in QA and at least 5 years in a quality role are required

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.


Medical Writer

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.

Responsibilities

  • Development, writing, editing, and finalization of clinical documentation required prior to the initiation of a clinical study, including clinical study protocols, informed consent documents and other clinical documentation given to volunteers
  • Development, writing, editing, and finalization of clinical documentation required for submission to regulatory health authorities and ethical review committees during the course of a clinical study, including interim safety report, abstracts for scientific presentation, and integrated summaries of efficacy and safety
  • Development, writing, editing, and finalization of clinical documentation required for study close-out including final clinical study reports, final safety reports, and manuscripts/scientific papers
  • Analysis of clinical data, compilation of clinical data tables, and integration of clinical data summaries into clinical study reports and manuscripts as appropriate
  • Coordination of team review and editing of clinical regulatory documentation in close collaboration with the Chief Medical Officer, Chief Executive Officer, Principal Investigators, and operational staff to develop quality study protocols, informed consent documents and other clinical documentation
  • Development of processes, templates and libraries, by creation of a Manual of Procedures to support creation of study protocols, study reports and other clinical documentation

Requirements

  • Bachelor's degree, Master's degree or PhD in science- or public health-related field
  • 3-5 years of prior vaccine trial experience is required
  • Excellent oral and written communication skills
  • 3-5 years of prior experience in writing and developing clinical documents such as clinical study reports, safety reports, and clinical protocols, as well as informed consent forms, and other clinical documentation provided to volunteers
  • Demonstrated knowledge of protocol structure, clinical data analysis and presentation
  • Demonstrated knowledge of GCPs
  • Strong analytical skills/excellent interpersonal skills/strong leadership abilities
  • Proven ability to demonstrate strong decision making and problem solving skills
  • Strong time management skills and the proven ability to meet deadlines
  • Basic knowledge of windows-based software programs
  • U.S. citizenship or permanent eligibility to work legally in the U.S. is required

 

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