Biotechnologists Specialists
2025-10-02T08:42:34+00:00
Pharmacy and Poisons Board
https://cdn.greatkenyanjobs.com/jsjobsdata/data/employer/comp_2627/logo/Pharmacy%20and%20Poisons%20Board,.png
https://www.greatkenyanjobs.com/employers/company-detail/company-Pharmacy-and-Poisons-Board,-2627/nav-42
FULL_TIME
Kenya
Nairobi
00100
Kenya
Public Administration, and Government
Health Professionals
2025-10-15T17:00:00+00:00
Kenya
8
Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the implementation of Lot Release for vaccines and biotherapeutics registration.
Job Specification
Duties and Responsibilities
- Interpreting test data relative to established specifications, standards, and control limits, and making recommendations on appropriateness
- Ensuring all vendors have been qualified and adhere to vendor qualification and performance standards with the aim of optimal utilization of equipment
- Reviewing test data from contract laboratories and external calibration service providers to ensure accuracy and regulatory compliance
- Using statistical methods and applying business and economic data in decision-making
- Identifying patterns in data that may indicate the test system is operating outside of specifications and investigating and troubleshooting when certain patterns exist
- Establishing corrective and preventive actions and ensuring review and follow-up
- Executing and approving/closing-out of laboratory investigations
- Systematically reviewing all operational procedures to identify potential risks and sources of non-compliance and areas that require improvement
- Reviewing of lot summary protocols and recommending for approval of lot release certificate
- Conducting and documenting regular safety inspections
- Ensuring compliance with the organization’s and regulatory Health and Safety Policies
- Establishing a waste management programme addressing the disposal of all hazardous, biological, pharmaceutical, and chemical waste
- Ensuring that analytical reports comply with standards and regulations
- Ensuring that procedures are carried out carefully and accurately to eliminate errors, by checking that all details have been considered
- Verifying analytical reports produced by other analysts
- Verifying the comprehensiveness of the tests, as well as the integrity and compliance of supporting documents, and ensuring follow-up of abnormalities
- Developing, installing, and revising validation procedures and protocols
- Writing and reviewing technical reports or documentation, such as deviation reports, testing protocols, and trend analyses
- Coordinating and tracking projects
- Training project teams and reporting performance metrics to supervisors
- Developing, maintaining, and abiding by project timelines and resource plans, and working directly with other team members to ensure deliverables meet target deadlines
- Ensuring integration of quality control functions with other regulatory functions
- Understanding and utilizing good control and inventory standards
- Evaluating performance of analytical methods and procedures to determine how they might be optimized and/or improved
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s Degree in Pharmacy, Biotechnology, Biochemistry, Molecular Biology, Microbiology, Biomedical Engineering, or any other relevant and equivalent qualifications from a recognized institution
- Have at least Eight (8) years of relevant work experience, three (3) of which must have been in a supervisory role
- Holding a Master’s Degree leading to recognition as a Specialist in Biotechnology, Vaccinology, Biotherapeutics, Immunology, Pharmaceutical Innovation & Drug Development, Molecular Biology, Pharmacotherapy, or equivalent qualifications from a recognized institution will be an added advantage
- Have certified courses in Biologics Development and Manufacturing, Vaccines Manufacturing, or Blood & Blood Products
- Hold professional certification and membership with a relevant professional body, where applicable, and be in good standing
- Possess a certificate in a management course lasting not less than four (4) weeks from a recognized institution
- Be proficient in computer applications
- Have demonstrated merit and ability as reflected in work performance and results
- Fulfill the requirements of Chapter Six of the Constitution
Interpreting test data relative to established specifications, standards, and control limits, and making recommendations on appropriateness
Ensuring all vendors have been qualified and adhere to vendor qualification and performance standards with the aim of optimal utilization of equipment
Reviewing test data from contract laboratories and external calibration service providers to ensure accuracy and regulatory compliance
Using statistical methods and applying business and economic data in decision-making
Identifying patterns in data that may indicate the test system is operating outside of specifications and investigating and troubleshooting when certain patterns exist
Establishing corrective and preventive actions and ensuring review and follow-up
Executing and approving/closing-out of laboratory investigations
Systematically reviewing all operational procedures to identify potential risks and sources of non-compliance and areas that require improvement
Reviewing of lot summary protocols and recommending for approval of lot release certificate
Conducting and documenting regular safety inspections
Ensuring compliance with the organization’s and regulatory Health and Safety Policies
Establishing a waste management programme addressing the disposal of all hazardous, biological, pharmaceutical, and chemical waste
Ensuring that analytical reports comply with standards and regulations
Ensuring that procedures are carried out carefully and accurately to eliminate errors, by checking that all details have been considered
Verifying analytical reports produced by other analysts
Verifying the comprehensiveness of the tests, as well as the integrity and compliance of supporting documents, and ensuring follow-up of abnormalities
Developing, installing, and revising validation procedures and protocols
Writing and reviewing technical reports or documentation, such as deviation reports, testing protocols, and trend analyses
Coordinating and tracking projects
Training project teams and reporting performance metrics to supervisors
Developing, maintaining, and abiding by project timelines and resource plans, and working directly with other team members to ensure deliverables meet target deadlines
Ensuring integration of quality control functions with other regulatory functions
Understanding and utilizing good control and inventory standards
Evaluating performance of analytical methods and procedures to determine how they might be optimized and/or improved
Be proficient in computer applications
Have demonstrated merit and ability as reflected in work performance and results
Fulfill the requirements of Chapter Six of the Constitution
Have a Bachelor’s Degree in Pharmacy, Biotechnology, Biochemistry, Molecular Biology, Microbiology, Biomedical Engineering, or any other relevant and equivalent qualifications from a recognized institution
Have at least Eight (8) years of relevant work experience, three (3) of which must have been in a supervisory role
Holding a Master’s Degree leading to recognition as a Specialist in Biotechnology, Vaccinology, Biotherapeutics, Immunology, Pharmaceutical Innovation & Drug Development, Molecular Biology, Pharmacotherapy, or equivalent qualifications from a recognized institution will be an added advantage
Have certified courses in Biologics Development and Manufacturing, Vaccines Manufacturing, or Blood & Blood Products
Hold professional certification and membership with a relevant professional body, where applicable, and be in good standing
Possess a certificate in a management course lasting not less than four (4) weeks from a recognized institution
JOB-68de3afae0d74
Vacancy title:
Biotechnologists Specialists
[Type: FULL_TIME, Industry: Public Administration, and Government, Category: Health Professionals]
Jobs at:
Pharmacy and Poisons Board
Deadline of this Job:
Wednesday, October 15 2025
Duty Station:
Kenya | Nairobi | Kenya
Summary
Date Posted: Thursday, October 2 2025, Base Salary: Not Disclosed
Similar Jobs in Kenya
Learn more about Pharmacy and Poisons Board
Pharmacy and Poisons Board jobs in Kenya
JOB DETAILS:
Job Purpose
The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the implementation of Lot Release for vaccines and biotherapeutics registration.
Job Specification
Duties and Responsibilities
- Interpreting test data relative to established specifications, standards, and control limits, and making recommendations on appropriateness
- Ensuring all vendors have been qualified and adhere to vendor qualification and performance standards with the aim of optimal utilization of equipment
- Reviewing test data from contract laboratories and external calibration service providers to ensure accuracy and regulatory compliance
- Using statistical methods and applying business and economic data in decision-making
- Identifying patterns in data that may indicate the test system is operating outside of specifications and investigating and troubleshooting when certain patterns exist
- Establishing corrective and preventive actions and ensuring review and follow-up
- Executing and approving/closing-out of laboratory investigations
- Systematically reviewing all operational procedures to identify potential risks and sources of non-compliance and areas that require improvement
- Reviewing of lot summary protocols and recommending for approval of lot release certificate
- Conducting and documenting regular safety inspections
- Ensuring compliance with the organization’s and regulatory Health and Safety Policies
- Establishing a waste management programme addressing the disposal of all hazardous, biological, pharmaceutical, and chemical waste
- Ensuring that analytical reports comply with standards and regulations
- Ensuring that procedures are carried out carefully and accurately to eliminate errors, by checking that all details have been considered
- Verifying analytical reports produced by other analysts
- Verifying the comprehensiveness of the tests, as well as the integrity and compliance of supporting documents, and ensuring follow-up of abnormalities
- Developing, installing, and revising validation procedures and protocols
- Writing and reviewing technical reports or documentation, such as deviation reports, testing protocols, and trend analyses
- Coordinating and tracking projects
- Training project teams and reporting performance metrics to supervisors
- Developing, maintaining, and abiding by project timelines and resource plans, and working directly with other team members to ensure deliverables meet target deadlines
- Ensuring integration of quality control functions with other regulatory functions
- Understanding and utilizing good control and inventory standards
- Evaluating performance of analytical methods and procedures to determine how they might be optimized and/or improved
Person Specifications
For appointment to this grade, a candidate must:
- Have a Bachelor’s Degree in Pharmacy, Biotechnology, Biochemistry, Molecular Biology, Microbiology, Biomedical Engineering, or any other relevant and equivalent qualifications from a recognized institution
- Have at least Eight (8) years of relevant work experience, three (3) of which must have been in a supervisory role
- Holding a Master’s Degree leading to recognition as a Specialist in Biotechnology, Vaccinology, Biotherapeutics, Immunology, Pharmaceutical Innovation & Drug Development, Molecular Biology, Pharmacotherapy, or equivalent qualifications from a recognized institution will be an added advantage
- Have certified courses in Biologics Development and Manufacturing, Vaccines Manufacturing, or Blood & Blood Products
- Hold professional certification and membership with a relevant professional body, where applicable, and be in good standing
- Possess a certificate in a management course lasting not less than four (4) weeks from a recognized institution
- Be proficient in computer applications
- Have demonstrated merit and ability as reflected in work performance and results
- Fulfill the requirements of Chapter Six of the Constitution
Work Hours: 8
Experience in Months: 24
Level of Education: bachelor degree
Job application procedure
interested applicant please, Click here to apply
All Jobs | QUICK ALERT SUBSCRIPTION
