Scientist: AMD - Talent Pooling

Biovac; Cape Town; On-site; ZAR 700,000 - 1,000,000; Full time

Job summary

Biovac is seeking a capable Scientist to drive S&I activities, including DoE design, analytical method development and method verification. You will lead design, planning and execution of experiments, interpret complex data, and ensure documentation and compliance within a biosafety level 3 setting.

The role emphasizes SME-level operation of analytical platforms, technology transfers, and rigorous adherence to cGMP and relevant pharmaceutical regulations, contributing to impactful vaccine

Qualifications

• Bachelor’s degree or diploma in Microbiology, Biochemistry, Chemistry or Process Engineering.
• MSc or equivalent industry experience.
• Experience with DoE protocols and analytical method development.
• Knowledge of cGMP and GLP guidelines.
• Ability to work under biosafety level 3 containment.

Responsibilities

• Design, plan and execute DoE protocols and related experiments.
• Perform laboratory experiments to support high-throughput and routine development.
• Execute analytical verification/qualification of existing methods and development of new methods.
• Prepare, analyze and interpret complex data sets; act as SME for relevant equipment.
• Assist with technology transfers from development to manufacturing, including clinical trial materials.
• Write and compile SOPs, WI and technical documentation.
• Ensure compliance with Medicines Act and Pharmacy Act, and internal policies.
• Support a strong quality culture aligned to cGMP.

Skills

DoE design

Analytical data interpretation

SOP/WI documentation

GxP knowledge

Team collaboration

Education

Bachelor’s degree or diploma in Microbiology/Biochemistry/Chemistry/Process Engineering or equivalent

MSc or equivalent industry experience

Job description

Are you interested in future career opportunities with Biovac?

We are continuously looking for talented professionals to join our talent pool. By submitting your application, your profile will be considered for future vacancies that match your skills, qualifications, and experience.

Job Purpose:

Responsible for S&I activities including but not limited to:

Designing, planning and execution of:

• Design of Experiment (DoE) protocols as required by the Analytical Method Development (AMD) Chemistry platform.

• Laboratory experiments in order to support high throughput development, routine development and release

• Execution of analytical verification / qualification of existing methods and development of new methods / strategies

• Collection, analysis, application and interpretation of complex data sets results

• Responsible as subject matter expert (SME) and operation of relevant equipment as it pertains to the Analytical platforms.

• Assist with technology transfers (inbound or outbound) from development to manufacturing, or manufacturing to manufacturing (including manufacture of material to be used in clinical trials).

• Responsible for writing and compiling of job related SOPs, WI and Technical documentation.

• Responsible to ensure that the (name of department) department and it’s respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements

• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures and other applicable laws

• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Requirements:

Required:

• Bachelor’s degree or diploma in Microbiology/Biochemistry/Chemistry/Process Engineering or equivalent

Preferred:

• MSc or equivalent industry experience

Experience & industry knowledge:

Required:

• Bachelor’s degree or diploma with relevant hands‑on experience or at least 2‑3 years practical experience in a similar position

• Strong experience in the Product development of vaccines and/or biologicals and associated equipment

• Exposure and understanding of scientific principles that governs production of vaccines and /or biologicals

• Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines

• Knowledge of bio‑safety principles. - Ability to work under biosafety level 3 containment

• Experience in having faced successfully local quality audits would be an advantage.

Preferred:

• Working knowledge of Pharmaceutical Manufacturing related legislation

• Experience in aseptic (sterile) manufacturing

• Experience in having faced successfully local and/ or international quality audits

• Experience in general business management within a commercial environment

Responsibilities:

Core Technical Delivery

• Laboratory Administration including Budgeting and Cost Control (Assists with group/ unit budgeting, follows a cost conscious culture within own department/ group/ unit)

• Ensure services are delivered to all internal and/ or external stakeholders as defined and as per agreed timelines

• Risk and Anticipation Mitigation to ensure that all work done is in accordance with current standards/processes and assist Senior Scientist/Group Leader to identify anticipated risks impacting group/ unit/ team

• Follow cGMP guidelines and ensure all Change Controls/ NCR’s etc. are effectively managed to support QA’s processes

• Mitigate obvious risks on site and submit job cards to address facility issues/ risks as per the process set by Engineering

• Close all actions assigned to self/ staff member as per EHS committee agreed deadlines

• Responsible for providing assistance, guidance, problem solving or input to the operational departments as required and agreed

• Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines

• Responsible for biological product and process development, which could include upstream (microbial cultivation) and down- stream processes (purification) and analytical method development (microbial, immunological, chemical)

• Responsible for experimental design, planning, execution, problem solving and recording

• Assist with technology transfers from development to manufacturing (including manufacture of material to be used in clinical trials)

• Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines

• Driving Innovation and Continuous Improvement

• Compilation of Deviations, Change Controls, CAPAs

• Communication:

• Ensure a timely and effective communication.

• Escalate quality issues to the appropriate levels of management.

Quality Management

• Building own, team and site’s GMP Knowledge and Compliance

• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives

• Participate in building a sustainable Quality Culture and proactive mitigate risks that may negatively impact quality or elevate these appropriately

• Ensure Deviations, Change Controls, CAPAs are handled effectively

• Advocate continuous improvement within own department as well as cross functionally

Closing Date: 13 April 2027