Job Title: Senior Researcher                     

Location : Addis Ababa, Ethiopia

Reports to: Director, Clinical Trials Directorate

Employment Type and Duration: Contract One year with possible extension subject to performance and budget availability

Salary : 19,820.00

House Allowance : 10,000.00

Mobile & Internet Allowance : 1,400.00

Required Number: 1 (One)

Background   

The Armauer Hansen Research Institute (AHRI) was founded in 1970 through the initiative of the Norwegian and Swedish Save the Children organizations seconded by the Ministry of Health of Ethiopia. The Institute got its name from the Norwegian physician, Gerhard Henrik Armauer Hansen, who first described the leprosy bacillus (Mycobacterium leprae). AHRI reorganized by the decree of the Council of Minister’s Regulation No. 530/2023 with the objectives of conducting biomedical, clinical trial and bioequivalence (BE) research, promoting and strengthening local production of pharmaceutical products and research capacity building under the Federal Ministry of Health. AHRI, over its 50 years in service, is well known for its hub function for skill and technology transfer and partnership embracing research agendas with direct impact in the development and transformation of population in Ethiopia. 

By virtue of the council of Ministers proclamation no. 530/2023, AHRI is mandated to develop capacity and lead bioequivalence studies in the country. The bioequivalence capacity building efforts started in 2012 when the regional bioequivalence center (RBEC) was established in Addis Ababa; since then in collaboration with RBEC and other partners AHRI has been striving build capacity and experiencing with a couple of BE studies. As a follow-up to these efforts AHRI plans to develop a full-fledged bioequivalence center with CRO operations within its newly built research complex in Addis Ababa, Ethiopia. Currently equipment and furniture are under procurement for furnishing new bio analytical laboratory, clinical laboratory, the clinical facilities including study wards and other volunteer and staff amenities. Bioequivalence centers are globally operating in somehow harmonized standards thus implementing quality by design is essential during development of a BE center and bio analysis service is key. Therefore, we are planning to recruit a senior Bio-analyst who is well versed with bio analytical methods and instrumentations.                         

Duties & Responsibilities:

Overall the senior researcher takes the lead in planning, establishing and operating a regulatory compliant and internationally competent bio analysis laboratory within the framework of bioequivalence/bioavailability services and beyond.  The following could be considered as key responsibilities

• Conduct a quick  assessment and  bench marking best practices elsewhere for modeling the scope of services 

  • Lead the design and layout of the bio analytical laboratory viz other associated services and oversee the necessary structural renovations. 

  • Oversee the procurement and installation of bio analytical laboratory equipment, supplies, reagents and necessary technologies.

  • Ensure the facilities are equipped with the necessary technologies and resources for efficient operation. 

  • Prepare and support implementation of quality standards for ensuring the bio analytical laboratory and other facilities of the center meet all the necessary regulatory and safety standards. Lead the preparation of SOPs and other necessary operational documents in compliance with applicable local and international regulatory requirements.

  • Prepare and lead analytical methods development for target molecules; prepare and review study protocols, reports, and relevant SOPs.

  • Lead and manage bio analytical lab studies 

  • Manage the routine analysis of biological samples using LC-MS/MS and other relevant technologies and interpret pharmacokinetic data for bioequivalence and bioavailability studies.

  • Coordinate with clinical teams to ensure alignment on study protocols and timelines.

  • Promote quality and collaboration; prepare for and participate in regulatory audits and inspections; foster a collaborative and educational environment within the lab.

  • Plan and propose innovative approaches to enhance laboratory processes and data quality.

  • Mentor, train and lead the lab team

  • Provide regular & other technical reports and recommend improvements.

Job Requirements

Qualifications

The senior analyst should have:

• Pre-PhD Research Experience: 6 Pharmaceutical analysis, Pharmaceutical Chemistry, Analytical chemistry, or related.

• Post-PhD Research Experience: Minimum 02 years of hands-on experience in bio analytical laboratory and instrumentations.  

Preferred Qualifications, experiences, and attributes:

• Working experience with regulatory environment. 

• Demonstrated experience in method development, optimization, and validation using HPLC, LC-MS/MS, UHPLC or related technologies.

• Proficiency in developing and validating analytical methods for pharmacokinetic studies.

• Proven track record of planning and executing bio analytical studies

• Familiarity with available lab standards and preparing for and participating in regulatory audits and/or inspections.

Publications

• Internationally Accepted Journal Publications:7 points 

How to Apply

Interested applicants who fulfilled the above requirements should submit the following documents through THIS LINK

• CV/resume (not more than 5 pages) including names for references and their contact info

• A cover letter (one page)