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.


Project Manager

The Project Manager will report to Sanaria's Chief Scientific and Medical Officers while supporting the Equatorial Guinea Malaria Vaccine Initiative (EGMVI) Stage 3 program. Primary program activities are the conduct of three clinical trials of Sanaria products in Tanzania and Equatorial Guinea (PfSPZ Vaccine, PfSPZ Challenge and PfSPZ-CVac). The Project Manager will support the development of work plans that address Stage 3 program objectives, and coordinate their execution in accordance with established timelines, using formal management tools.

Essential Duties and Responsibilities

  • Create work plans that address Stage 3 program objectives using formal management tools, in coordination with Sanaria's clinical and administrative staff
  • Coordinate the implementation of these work plans according to established timelines and within budgetary and logistical constraints
  • Monitor the activities and progress of personnel and institutions, encourage timely completion of tasks, recommend corrective actions as needed, and continually update senior staff regarding project status
  • Facilitate communication between Sanaria and project sites, and among all appropriate stakeholders, using efficient conferencing methods (teleconferences, internet conferencing, webinars, etc.)
  • Write, circulate for revision, finalize and distribute minutes of conferences including action items; assure their timely completion and reporting
  • Develop budgets to support work plans and coordinate and monitor budget execution with Sanaria administrative staff
  • Coordinate work plans and their execution internally with relevant Sanaria staff, including clinical, manufacturing, logistics, quality, immunology and international projects; assure that timelines and documents are interfaced with those of counterparts in these areas, to achieve seamless project execution
  • Responsible for clinical formulation studies
  • Maintain tickler files to assure timely completion and submission of reports and other documents, and timely renewal of expiring approvals, agreements or policies
  • Write cover letters, applications, presentations and reports in coordination with other Sanaria staff as needed

Qualifications

  • Bachelor's degree (Master's degree preferred)
  • 5 + years related project management experience, preferably in clinical product development in an international context
  • Expertise with project management techniques and tools
  • Project Management Institute (PMI) Certification required: Project Management Professional (PMP) or Program Management Professional (PgMP) or PMI Scheduling Professional (PMI-SP)
  • Expertise and comfort in managing and facilitating objectives within a complex cross-functional matrixed international project
  • Ability to make effective presentations on general topics to internal and external stakeholders
  • Excellent verbal, written, and interpersonal and organizational skills
  • Ability to adapt plans and priorities to rapidly shifting project goals

Preferred

  • Knowledge of infectious diseases including malaria and public health
  • Experience working in Africa
  • Knowledge of financial terms and principles; ability to forecast and prepare budgets
  • Knowledge of financial/business analysis including the preparation of reports
  • Leadership experience

Physician Investigator

The Physician Investigator will support Equatorial Guinea Malaria Vaccine Initiative (EGMVI) Stage 3 activities on site in Malabo, Equatorial Guinea for the duration of the project, approximately four years. The physician must be fully bilingual (written and spoken Spanish and English) and experienced in clinical research/field epidemiology. This position will be the local Sanaria project director, interact closely with onsite collaborators, partners, and contractors, and assure that Sanaria's project objectives are met. Periodic visits to other sites in Africa, especially Tanzania, where Sanaria is sponsoring research trials, to represent Sanaria's interests in similar fashion, will be an important responsibility. This role will maintain frequent and comprehensive communication links with Sanaria Clinical personnel and report to the Chief Medical Officer.

Essential Duties and Responsibilities

  • Liaise with EGMVI collaborators including other Sanaria staff on site to accomplish Sanaria's research objectives
  • Assure adherence to Good Clinical Practices by all clinical research activities and personnel, with an emphasis on research volunteer safety
  • Assure the integrity of all clinical data
  • Carry out work plans/project activities, and maintain project timelines
  • Support local protocol development, protocol approvals, and clinical trial execution, including on-site monitoring and quality control
  • Communicate regularly and frequently with Sanaria clinical staff
  • Author written project reports and other documents
  • Serve an ambassadorial function, promoting excellent collaborative relationships with partners and host nationals
  • Attend meetings of the International PfSPZ Consortium and other meetings, as tasked
  • Conduct at least yearly visits to Sanaria's contracted Occupational Health physician

Qualifications

  • Doctor of Medicine degree and post-graduate medical training
  • Licensure to practice medicine in home country
  • 5+ Years of clinical research/field epidemiology experience, ideally in the setting of international partnerships
  • Good clinical practices certification
  • Basic and advanced cardiac life support certification
  • English and Spanish language fluency

Preferred

  • Ability to speak French
  • Board Certification in a primary care specialty (e.g. internal medicine, pediatrics, family medicine)
  • Infectious diseases fellowship training

Work Environment

The incumbent will be housed in Equatorial Guinea and provided transportation and security according to the standards of our administrative partner Medical Care Development International (MCDI). MCDI maintains American and other foreign national staff full-time in Malabo with security and health established as high priorities. Quality office space will be provided that is co-located with colleagues and collaborators to assure a congenial professional environment. Environmental hazards include potential exposure to human blood and to local disease hazards including identified and unidentified transmissible agents. Living in Equatorial Guinea may involve capricious events including police stops, local disturbances, inclement weather, and travel hazards.


Director of Quality

The Director of Quality 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 both QA and QC functions and will define processes or improve processes for receiving, manufacturing, packaging, testing and distribution for the clinical vaccine.

Essential Duties and Responsibilities

  • Responsible of daily QA activities and related cGMP compliance
  • Clinical Product release and COA generation
  • Manage deviations, investigations, OOS and CAPA
  • Manage stability program
  • Raw data review for GXP reporting
  • Change Control Management
  • Internal audits and external vendor Audit
  • Responsible for clinical formulation studies
  • Manage QC testing
  • Perform GXP training
  • Oversee equipment validations
  • Oversee assay qualification
  • Work directly with the Senior Management to assure both continuous improvement of the Quality System and provide leadership for the overall Quality Management system
  • Manage 2-5 technical professionals in the quality group

Knowledge and Abilities

  • 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
  • The ability to work in a fast paced environment with multiple and competing priorities is essential
  • Education, Work Experience and/or Licensure
  • 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 QC and at least 5 years in a quality role are required. U.S. citizenship or permanent resident status is required

 

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