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:

Project Manager
Medical Writer
Facilities Engineer
Accounting Associate
Research Associate - Mosquito Production Team
Research Associate - Gametocyte Production

Project Manager

The Project Manager will report to Sanaria's Chief Scientific Officer 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.

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
  • 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

Requirements

  • 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, including Gantt charts, Microsoft Project, etc
  • 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

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

Facilities Engineer

The Quality Engineer will work closely with Facilities and Manufacturing departments to review, approve and support utility and equipment deviations, validation studies, change controls, work orders and calibration. The Quality Engineer will ensure that testing performed is consistent with approved protocols, policies, guidelines and SOPs. The incumbent will write, review, analyze and revise written SOPs and submit procedural changes necessary to meet regulatory requirements. The Quality Engineer will also schedule, oversee and approve contractors' work on equipment calibrations, preventive maintenance, cleaning of cleanrooms and laboratories, and repairs. The Engineer will create Quality documents and reports including protocols, qualifications, and regulatory submissions. This position will support the manufacturing process with timely closure of observations/audit items.

Qualified candidates must have a BA/BS degree in engineering or science (chemistry, biology preferred) with 2-5 years of relevant experience in a GMP manufacturing environment. The successful candidate will have a good understanding of the Code of Federal Regulations, GxPs, FDA regulations governing validated applications including (21 CFR Parts 11, 210, 211, 820). Experience in equipment, utilities, computer systems, and facility validations is essential. The position also requires excellent communications skills and demonstrated experience writing SOPs and validation protocols. U.S. citizenship or permanent eligibility to work legally in the U.S. is required.


Accounting Associate

Reporting to the Controller, the Accounting Assistant will maintain compliant records of all grants, contracts, sales and support agreements; track receipt and disbursement of funds in accordance with GAAP and agreement terms; monitor revenue and expenditures against approved budgets; support budget development and the grants and contracts application process; analyze the company financial position and present reports to management; and prepare required external financial reports.

The Accounting Assistant will support the Controller, CEO, CLO and Executive team by tracking and analyzing companies' financial performance against the annual budgets and short and long-term business strategies as developed by management. The incumbent will also maintain compliant policies and procedures and assist with external audits.

Qualified candidates must have a BA/BS degree in accounting, business or a related field, with 0-2 years of experience completing day-to-day financial transactions, accounts payable/receivable, GL entries and monthly close. Experience monitoring revenue and expense against budgets, financial analysis and development of advanced financial reports a plus.

The successful candidate must have strong collaboration and communication skills, excellent computer-based analytical skills, knowledge of accounting and financial management systems and be an expert Quick Books and Excel user.

U.S. citizenship or permanent eligibility to work legally in the U.S. is required.


Research Associate - Mosquito Production Team

The Research Associate will perform key operations during manufacture of Sanaria's PfSPZ Vaccine and other products that may include mosquito production; mosquito dissection; formulation, revision and development of SOPs and batch records for the aseptic mosquito production and vaccine manufacture; review of batch records; monitoring the sporogonic development of the malaria parasites in mosquitoes; transfer of aseptic mosquitoes for vaccine manufacture, oocyst assessments vialing or cryopreservation of final product, or other component procedures. The Research Associate will also work on in vitro production of sporozoites, quantifying transmission blocking activity using fluorescent microscopy and standard membrane feeding assays.

Qualified candidates must have a Bachelor's or Master's degree in Biology or a related scientific field with some practical experience in sterile technique, microscopy, and cell/tissue culture. Experience with GMP manufacturing is a plus. The successful candidate must have excellent communication, writing, team work and organization skills. Flexibility and the willingness to learn new experimental and operational techniques are essential. U.S. citizenship or permanent eligibility to work legally in the U.S. is required.


Research Associate - Gametocyte Production

The Research Associate will be involved in the malaria PfSPZ vaccine production process. This position involves but not limit to aseptic techniques, maintenance of parasite cultures and other aspects of GMP Manufacturing including mosquito dissection; revision and development of SOPs and batch records for Gametocyte Production team; conducting standard membrane feeding assays (SMFA) and vailing PfSPZ vaccine. The incumbent is also expected to participate in research projects targeted at optimizing the efficiency and scaling up of procedures.

Qualified candidates must have a degree in Biology or related discipline and 3 years of relevant experience. Excellent communication and interactive skills and the willingness to learn new experimental techniques are required. Experience with sterile technique, microscopy and cell culture is desirable. A background in bio-engineering is a plus. U.S. citizenship or permanent eligibility to work in the US is required.

 

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