LonAdd HR Consultancy Plc (www.lonadd.com) is a Recruitment & Outsourcing Company based in Addis Ababa, Ethiopia, with branch offices in Dukem, Hawassa and Bahir Dar. We are looking to recruit a qualified candidate on behalf of our client.

Location: Addis Ababa at AHRI

Quantity Required – 1 (One)

Contract duration:- 1 year with the possibility of extension based on satisfactory performance.

Start date – as soon as possible

Background and Purpose of the Position

The Government of Ethiopia, with support from the World Bank, is implementing the Health Emergency Preparedness, Response and Resilience (HEPRR) Multiphase Programmatic Approach to strengthen health-system resilience, preparedness and response capacities, including strengthening local pharmaceutical manufacturing and related technical and regulatory capacities. Within this framework, the Armauer Hansen Research Institute (AHRI), a national biomedical research institution with extensive experience in biomedical research, clinical trials and bioequivalence studies, is strengthening its capacity to support local pharmaceutical manufacturing and research. Under Council of Ministers Regulation No. 531/2023, AHRI leads bioequivalence studies in Ethiopia and is working to establish a fully operational Bioequivalence Center with Contract Research Organization capabilities within its new research complex, including appropriately equipped bioanalytical and clinical laboratories.

The purpose of the Senior Bio-Analyst position is to provide expert technical leadership for the design, establishment and operation of a regulatory-compliant and internationally competent bioanalytical laboratory within AHRI’s Bioequivalence/Bioavailability Center. The position will lead bioanalytical method development and validation, management of bioanalytical studies, analysis of biological samples and interpretation of pharmacokinetic data, while ensuring implementation of applicable quality, regulatory and safety standards. The Senior Bio-Analyst will also support laboratory-systems development, regulatory readiness, capacity building and adoption of appropriate technologies to strengthen AHRI’s capacity to deliver high-quality BE/BA services and support Ethiopia’s local pharmaceutical-manufacturing agenda.

Justification

AHRI requires dedicated senior bioanalytical expertise to design and operationalize compliant laboratory facilities, establish validated analytical methods and documentation, manage studies, ensure regulatory and safety readiness, adopt appropriate instrumentation, and build sustainable local capacity for high-quality BE/BA services.

Objectives Purpose and Expected Results

The assignment will establish and operationalize an internationally competent, regulatory-compliant bioanalytical laboratory; develop and validate methods for target molecules; support high-quality BE/BA studies and pharmacokinetic analysis; implement quality, safety and regulatory systems; strengthen laboratory infrastructure and technology readiness; and develop sustainable technical capacity within AHRI.

Description of the Assignment

The Senior Bio-Analyst will provide technical leadership for planning, establishing and operating a regulatory-compliant bioanalytical laboratory within AHRI’s BE/BA Center. The position will lead methods and studies, support laboratory infrastructure and technology readiness, ensure compliance with quality and regulatory standards, and strengthen the laboratory team’s technical capacity.

Job Requirements

Education:

• MSc or PhD in Pharmaceutical Analysis, Pharmaceutical Chemistry, Analytical Chemistry or another relevant field.

Experience:

• Minimum of five years of experience in a bioanalytical laboratory and instrumentation.

• Preferred experience includes regulatory environments; analytical-method development, optimization and validation using HPLC, LC-MS/MS, UHPLC or related technologies; pharmacokinetic analytical methods; planning and executing bioanalytical studies with clinical-team coordination and protocol adherence; biological-sample analysis and pharmacokinetic-data interpretation; statistical software and data integrity; applicable laboratory standards; and regulatory audits or inspections.

Duties and Responsibilities

• Conduct a rapid assessment of current opportunities and foreseeable challenges in bioanalytical laboratory operations within the BE/BA industry and beyond, benchmark international best practices, and define the appropriate scope of laboratory services for AHRI.

• Lead the design and layout of the bioanalytical laboratory and associated services and oversee necessary structural renovations.

• Follow up procurement and installation of bioanalytical laboratory equipment, supplies, reagents and required technologies.

• Ensure laboratory facilities have the technologies and resources required for efficient operation.

• Implement quality standards so the bioanalytical laboratory and other BE/BA facilities comply with applicable regulatory and safety standards.

• Lead preparation of SOPs and other operational documents in accordance with applicable national and international regulatory requirements.

• Lead bioanalytical-method development for target molecules and prepare and review study protocols, reports and relevant SOPs.

• Lead and manage bioanalytical studies, ensuring appropriate planning, implementation and documentation.

• Analyze biological samples using LC-MS/MS and other relevant technologies and interpret pharmacokinetic data from BE/BA studies.

• Coordinate with clinical teams to align bioanalytical and clinical activities with agreed study protocols and timelines.

• Prepare for and participate in regulatory audits and inspections related to the bioanalytical laboratory and BE/BA activities.

• Foster a collaborative and educational laboratory environment that promotes teamwork, learning and technical development.

• Identify and propose innovative approaches to improve laboratory processes and strengthen data quality.

• Train and lead the laboratory team, developing sustainable local technical capacity in bioanalytical laboratory operations.

• Prepare regular progress reports and recommend improvements to strengthen laboratory establishment, operation and performance.

Deliverables and Reporting

Major Task

• Conduct a rapid assessment of current opportunities and foreseeable challenges in bioanalytical laboratory operations within the BE/BA industry and beyond, benchmark international best practices, and define the appropriate scope of laboratory services for AHRI.

• Lead the design and layout of the bioanalytical laboratory and associated services and oversee necessary structural renovations.

• Equipment procurement, installation and technology readiness

• Implement quality standards so the bioanalytical laboratory and other BE/BA facilities comply with applicable regulatory and safety standards.

• Lead preparation of SOPs and other operational documents in accordance with applicable national and international regulatory requirements.

• Lead bioanalytical-method development for target molecules and prepare and review study protocols, reports and relevant SOPs.

• Bioanalytical-study execution, sample analysis and pharmacokinetic interpretation.

• Prepare for and participate in regulatory audits and inspections related to the bioanalytical laboratory and BE/BA activities.

• Train and lead the laboratory team, developing sustainable local technical capacity in bioanalytical laboratory operations.

• Identify and propose innovative approaches to improve laboratory processes and strengthen data quality.

• Prepare regular progress reports and recommend improvements to strengthen laboratory establishment, operation and performance.

Deliverables

• Bioanalytical Laboratory Assessment Report - Opportunities, challenges, international good practices and recommendations defining the scope of BE/BA laboratory services.

• Bioanalytical Laboratory Design and Operationalization Plan - Design, layout, technical requirements, structural-renovation recommendations and associated services

• Equipment and Technology Readiness Report - Procurement, installation and operational readiness of equipment, supplies, reagents and technologies.

• Quality and Regulatory Compliance Framework - Quality, regulatory and safety requirements established and implemented.

• Standard Operating Procedures and Operational Documents - Required documents developed in accordance with national and international regulatory requirements.

• Bioanalytical Methods and Validation Documentation - Methods for target molecules developed and validated, with protocols, SOPs and technical reports.

• Bioanalytical Study Reports - Completed studies, biological-sample analysis using LC-MS/MS or related technology, and pharmacokinetic-data interpretation.

• Regulatory Audit and Inspection Readiness Documentation - Required documentation and preparations completed.

• Laboratory Capacity-Building Outputs - Training and mentorship on methods, operations, quality systems and technologies.

• Laboratory Process and Data Quality Improvement Recommendations - Recommendations developed and implemented to improve efficiency and data quality

• Regular Progress Reports - Progress, achievements, challenges and recommendations for laboratory establishment and operation.

Project Management

• The Senior Bio-Analyst will report to the Clinical Trial Directorate at AHRI and coordinate with clinical teams, laboratory personnel, procurement and infrastructure teams, regulators and the wider BE/BA Center. Client will provide contract oversight through the institutional third-party HR service arrangement.

General Conditions Procedures and Logistics

Payment Modality and Schedule

• The salary will be paid on a monthly basis by LonAdd upon successful completion of the monthly deliverable.

Policy Conditions

• The HR firm will manage all administrative issues and aspects based on HR policies and procedures.

• All remuneration must be within the contract agreement through the HR firm.

• No contract may commence unless the contract is signed by both the HR firm and the consultant.

• Consultants will not have supervisory responsibilities or authority over the Client budget. 

Skills & Competencies

Technology Skills

• Demonstrated use of HPLC, LC-MS/MS, UHPLC or related technologies for method development, optimization and validation; analytical-method development for pharmacokinetic studies; LC-MS/MS and related technologies for biological-sample analysis; statistical software for data analysis and data integrity; and bioanalytical laboratory instrumentation and associated technologies.

Language Requirements

• Good command of English, both spoken and written.

Core Competencies

• 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 ability in planning and executing bioanalytical studies, including coordination with clinical teams and adherence to study timelines and protocols.

• Extensive experience in analyzing biological samples and interpreting pharmacokinetic data.

• Proficiency in statistical software for data analysis and ensuring data integrity.

• Familiarity with applicable laboratory standards.

• Ability to prepare for and participate in regulatory audits and/or inspections.

• Experience working within a regulatory environment.

How To Apply

Interested applicants with the appropriate qualifications and experience should submit their most recent and detailed CV only, via email to recruitment@lonadd.com , by putting Application for ‘’ Senior Bio Analyst ‘’ in the subject box.

Only Shortlisted Candidates will be contacted

Application Deadline September 30, 2026

Job Requirements Master's Degree or PhD in Pharmaceutical Analysis, Pharmaceutical Chemistry, Analytical Chemistry or another relevant field with relevant work experience How to Apply Interested applicants with the appropriate qualifications and experience should submit their most recent and detailed CV only, via email to recruitment@lonadd.com , by putting Application for ‘’ Senior Bio Analyst ‘’ in the subject box.