[Closing date: May 21, 2017]
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases (www.dndi.org).
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership, a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.
Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.
Purpose of the position
The Pharmaceutical Development Supply Officer coordinates API and drug product supply activities. S/he also provides support to the whole Pharmaceutical Development team.
S/he works to the necessary standards of GLP, GMP and GDP.
Specific job responsibilities
- Support the development and maintenance of supply forecasts for API and drug products.
- Support the generation of supply-related materials such as requests for proposals, material safety data sheets, questionnaires etc.
- Support the identification of suppliers and procurement activities.
- Maintains an up-to-date project schedule and communicates technical issues or deviations that need to be addressed in a timely manner.
- Interacts with all internal and external project partners on a regular basis to track activities and progress.
- Ensures that all activities follow applicable GLP/GMP/GDP standards, DNDi SOPs and other regulatory requirements, with a view to eventual product registration.
- Develops and maintains records of API and drug product inventories, to monitor critical stock levels and expiry dates.
- Prepares monthly written reports for internal project teams and other stakeholders, as necessary.
- Support the preparation of clinical trial applications and other regulatory documentation.
- Manage designated project and vendor audit-related documentation in SharePoint according to DNDi SOPs.
- Manage CMC documentation on SharePoint and the secure archival of documentation according to DNDi SOPs.
- Support the operation and implementation of DNDi Pharmaceutical Quality System.
- Undertake continuous improvement initiatives within the Pharmaceutical Development Team.
- Provide logistical and administrative support for the Pharmaceutical Development team, including the organization of meetings and preparation of minutes.
- Any other support as requested by the Head of Pharmaceutical Development.
Skills and Attributes
- Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
- Clear and systematic thinking that demonstrates good judgment and problem solving competencies.
- Very good communication skills in multicultural, multi-lingual environments.
- Ability to work effectively as part of a multicultural team.
- Ability to work in a well-organized, structured manner and with attention to quality.
- Very good analytical skills.
- Ability to contribute to the project delivery under minimum supervision.
- Ability to manage small projects if delegated by upper levels with supervision.
- Strongly supportive of the DNDi mission and vision, and understanding the organization’s values and business model.
- Willingness to undertake limited travel (<10%) as dictated by project needs.
R&D technical skills
- Good knowledge of GLP, GMP and GDP.
- Minimum of 3 years’ experience with graduate degree, at least one year with post graduate degree.
- Recent experience (in last three years) of planning and forecasting in an R&D setting.
- Proven ability to work effectively in a team environment and matrix structure.
- Graduate or post graduate degree in pharmacy, chemistry or closely-related disciplines.
- Fluency in English.
- Proficiency in French desirable.
- Good knowledge of Microsoft Suite more specifically with Excel and Word.
- Good knowledge of project management software.
- Deadline for application: May 21st, 2017.
- Only shortlisted candidates will be contacted.
- Part-time position – 80%.
- Fixed term contract – 6-month – Starting ASAP.
- There is the possibility of further renewal after this date.