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:

Trial Master File (eTMF) Specialist - Clinical Research Associate
Physician Investigator, Malabo, Equatorial Guinea
Manufacturing Manager
Regulatory Affairs Specialist
Document Control Specialist

Trial Master File (eTMF) Specialist - Clinical Research Associate

The eTMF Specialist 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 focus on the retrieval, tracking and maintenance of clinical study documents in Sanaria's electronic Trial Master File (eTMF) and ensuring that all study documents are in place at the start of trials and collected at the close of trials.

The eTMF Specialist will maintain and support Veeva Vault eTMF software, perform validation, and provide training to company and study site staff. The eTMF Specialist will liaise with the data management vendor to resolve database issues. The Specialist will also help to organize and conduct sponsor/site teleconferences; assist with IRB document submission; assist with review of clinical documents (e.g. protocols, consent forms, study templates, SOPs, case report forms, etc.), help to develop and write SOPs for the Clinical Department.

This position is office-based and Rockville, Maryland. This is a perfect opportunity for a detail-oriented clinical research professional with strong document management and communication skills to work on research to address one of the world's top public health problems. Experienced CRAs/monitors looking to step back from travel assignments encouraged to apply.

Qualified Candidates will have a BA/BS degree in a health or science field, 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.


Physician Investigator, Malabo, Equatorial Guinea

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 2-3 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. The physician investigator will maintain frequent and comprehensive communication links with Sanaria Clinical personnel and report to the Chief Medical Officer.

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.

Manufacturing Manager

Sanaria's vaccine production is based on the life cycle of the parasite. Sanaria is producing material intended for Phase 3 trials and launch. Sanaria's manufacturing is a team-based environment.

The Manufacturing Manager will be working closely with individual manufacturing teams along with Quality and Operations to achieve Sanaria's manufacturing goals. The Manufacturing Manager will be responsible for the daily operations of Sanaria vaccine production reporting to the Executive Vice President of Process Development and Manufacturing.

Knowledge of aseptic operations and support systems is essential. A strong working knowledge of the regulatory compliance requirements for the production of biologics used in clinical studies and commercial manufacturing are essential. Demonstrated managerial skills, written and communication capabilities, and inter personal skills is necessary. The Manufacturing Manager must remain current regarding technical manufacturing requirements and must be able to develop/modifies production methods to fully address such issues. The Manufacturing Manager prepares validation protocols, SOPs, and master batch records. The Manufacturing Manager manages manufacturing operations assuring compliance with appropriate regulatory standards including but not limited to the Code of Federal Regulations (CFR), EMA Regulations, aseptic manufacturing, and/or Guidance documents such as U.S. FDA Points to Consider (PTC).

Responsibilities

  • Day-to-day activities of the manufacturing with respect to scheduling of production, operations and materials management activities.
  • Investigate and resolve problems.
  • Identify and implement process improvements.
  • Responsible for managing the training and development of personnel.
  • Responsible for interfacing and relationship development with all support departments (QC, QA, Facilities, Development, etc.) to assure production goals are met.
  • Tracking and trending critical process parameters and critical quality parameters.
  • Working with process development to review new process equipment compliance to GMP regulations and aseptic process requirements.

Qualifications

  • BS/BA degree required in biological sciences, biotechnology or life sciences.
  • Masters in biological sciences preferred.
  • 3 to 5 years of work experience in pilot or commercial biologics manufacturing plant under cGMP requirements.
  • 2 to 3 years prior management experience.

Regulatory Affairs Specialist

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 Regulatory Affairs Associate experienced with US (and preferably international) regulatory requirements and procedures, ideally with background in vaccine (or drug) development.

Responsibilities

  • Support regulatory submissions (INDs, Master Files, CTAs, IMPDs, BLA, etc) for product development process
  • Responsible for preparation and submission of standard regulatory documentation to support regulatory filings including, but not limited to, CMC and clinical amendments, IND annual reports, Investigator's Brochure (IB), safety reports, clinical trial progress reports
  • Responsible for development and review of CMC modules in coordination with the Manufacturing team to ensure CMC updates and reporting requirements are met
  • Work in close collaboration with the clinical and data teams to obtain the necessary clinical data and to develop clinical summaries and data presentation for IND annual reports, IBs and safety reports
  • Development, writing, editing, and finalization of Investigator's Brochure for submission to regulatory authorities
  • Development of regulatory documents in accordance with eCTD requirements
  • Coordination of team review and editing of regulatory documentation in close collaboration with Sanaria's Clinical, Manufacturing and Quality teams, and external collaborators - Principal Investigators and site clinical staff
  • Track and manage submissions and timelines for the regulatory filings
  • Development of SOPs, working instructions and document templates
  • Register and maintain Sanaria's clinical trials information on the clinicaltrials.gov registry and EudraCT database

Qualifications

  • Bachelor's or Master's degree in science- or public health-related field
  • 1-4 years of prior FDA regulatory experience in drugs/biologics is required
  • Excellent oral and written communication skills
  • 1-4 years of prior experience in writing and developing regulatory documents such as clinical, non-clinical and CMC sections of INDs, BLA, DMFs, amendments, annual reports and IBs
  • Experience with eCTD is required
  • Demonstrated knowledge and understanding of US and/or international regulations related to clinical trials and licensure/marketing applications
  • Strong analytical skills/excellent interpersonal skills/strong leadership abilities
  • High attention to detail and strong organization and time management skills
  • Excellent computer skills (Microsoft Office Suite)
  • U.S. citizenship or permanent eligibility to work legally in the U.S. is required

Document Control Specialist

Sanaria is seeking a Document Control Specialist for a unique and challenging opportunity for a world-class team working on the development and commercial manufacturing of a live sporozoite-based malaria vaccine that provides effective long-term immunity and lays the groundwork for eradication of malaria in areas where it is endemic.

We are looking for a highly organized and motivated Document Control Specialist with excellent customer service skills and acute attention to detail. This individual must be capable of working in a fast paced environment and able to make decisions based on policy and procedures. Prior experience with implementing electronic document management systems (EDMS) is a plus.

Responsibilities

  • Enforce GMP requirements and QA policies with regard to documentation, including document formatting and Good Documentation Practices (GDP).
  • Manage electronic and or paper document change requests (DCRs).
  • Administer document change control including tracking, controlling, and managing manufacturing documentation and review.
  • Administer control document issuances by making copies of master documents, stamping, distributing and tracking copies.
  • Maintain files for manufacturing, QC, QA, Safety, Materials Control and Equipment/Facilities.
  • Assign and track final product and intermediate Lot numbers.
  • Issue and track labels.
  • Review equipment logs.
  • Review Materials Control documentation.
  • Provide excellent customer service to internal customers, ensuring adherence to department timelines.
  • Write and or revise Document Control procedures and policies.
  • File documents in the QA archive; retrieve documents from the archive upon request.
  • Provide support during regulatory and other inspections; maintain a state of inspection readiness.

Qualifications

  • Minimum of a Bachelor's degree, preferably in Biochemistry, Biology, Chemistry, or other scientific field and 2+ years of GMP documentation experience.
  • Experience with implementing EDMS.
  • Familiarity with ICH and FDA guidelines, GMP regulations, and quality compliance requirements preferred.
  • Excellent writing skills and editing, formatting, and organization skills.
  • Excellent attention to detail and customer service attitude.

 

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