The KEMRI-Wellcome Trust Research Programme (KWTRP) in Kenya and Hilleman Laboratories in Singapore are pleased to offer 12-month apprenticeships in vaccine development and biomanufacturing for African scientists. The apprenticeship scheme aims to expand the technical knowhow and capability for sustainable end-to-end vaccine development and manufacture in Africa by providing hands-on exposure to process development, manufacturing operations, regulatory affairs, and other relevant functions at the Hilleman Laboratories. The intended outcome is an increase in the workforce in Africa with the knowhow and experience in end-to-end vaccine development and biomanufacture.
Scope
The 12-month apprenticeship scheme targets nationals/citizens of African countries with an MSc-level educational background in the life or physical sciences (including microbiology, biotechnology, immunology, chemistry, engineering among others). Applicants will have to articulate how the experience gained during the apprenticeship will be applied upon returning to their home country. The apprenticeship is free of charge for successful participants. Travel (flights and visa fees), accommodation and living expenses will be covered by KWTRP.
RESPONSIBILITIES:
During the 12-month training period, the Apprentice will participate in job rotations across one or more of the following function’s:
A. Process Development:
- Gain insights into the scale-up and optimisation of vaccine manufacturing processes and technology transfer activities.
- Collaborate with teams to inmprove process efficiency and yield.
B. Analytical Development:
- Learn about techniques for evaluating vaccine identity, purity, potency, and stability. Assist in the development and validation of analytical methods for vaccine characterization, in-process testing and release testing of both drug substance and drug product.
C. Formulation Sciences and Drug Product Development:
- Learn to design and execute phase-appropriate DP formulation development, process development, process characterization, and process validation studies.
D. Preclinical vaccine development:
- Exposure to the design and execution of animal studies in early development of novel vaccines. In person attendance to the animal facility might not be possible as it requires training and regulatory approval, however the fellow will be involved in major steps of the discussion around concept, planning and execution of news studies, and interpretation of results.
E. Regulatory Compliance:
- Learn about regulatory guidelines and their application in vaccine development. Participate in documentation and reporting for compliance purposes.
F. Cross-Functional Exposure:
- Engage in collaborative projects involving different departments to gain a holistic understanding of vaccine development.
G. Manufacturing Operations:
- Participate in the production of Drug Substances and Dmg Product of vaccine and biologics.
- Develop/ Follow Standard Operating Procedures (SOPs) and adhere to safety protocols. Support Manufacturing/ Engineering Operations for establishing EHS Guidelines, risk assessment, procedures and adhering to the procedures.
- Aid in the qualification of the facility and equipment to ensure that fit of Purpose is met.
H. Upstream Processing:
- Assist in cell culture and fermentation processes.
- Participate in media and buffer preparation.
- Monitor bioreactors and troubleshoot issues.
I. Downstream Processing:
- Learn about purification techniques such as chromatography and filtration.
- Support the purification of vaccine and biologics molecules.
J. Validation
- Assist with carry out validation activities associated with the manufacture of biologics and vaccines at the clinical manufacturing facility.
- Responsible for completing the validation objectives such as commissioning, qualifications (DQ, IQ, OQ, PQ) of equipment, facilities, utilities, autoclave, and cleaning validations.
K. Quality Control:
- Contribute to sample collection, testing, and analysis. Gain insights into quality assurance and compliance.
L. Quality Assurance
- Review SOPs, review executed batch records for bulk drug substance, drug product, and
- packaged clinical trial material.
- Assess and evaluate the change control.
- Identify quality risk and participate in the quality risk assessment to address the risk. Contribute to, support, and review investigations (deviations, laboratory investigations).
Eligibility
Applicants are required to have the following qualifications to be eligible for the apprenticeship.
- National or citizen of an African country
- Educational background in life or physical sciences, with MSc at a minimum (preference will be given to candidates that completed their MSc in the last 3 years).
- Have at least an intermediate level of spoken and written English language.
- Demonstrate in the application the relevance of the apprenticeship to personal career ambitions.
- Strong passion for vaccine research, development, and manufacturing as evidenced by previous work (e.g., university project, publications, relevant employment etc.).
- Curious, enthusiasm for learning, unquestionable integrity, and a proactive attitude.
Deadline for submission of proposals
All applications must be submitted online at https://jobs.kemri-wellcome.org/webform/kwtrphl-apprenticeship-application-form by 6th December 2023, 1700HRS (East African time). The receipt of the applications will be automatically acknowledged via return email from [email protected].
Diversity, Equality, and Inclusion
KWTRP and Hilleman Laboratories are committed to Equality, Diversity, and Inclusivity in science. Qualified applicants are encouraged to apply irrespective of gender identity, sexual orientation, ethnicity, religious, cultural, and social backgrounds, or (dis)ability status.
