Stability Scientist

Cape Town - South Africa

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa with our core purpose being to protect life. We are looking to hire a dynamic passionate confident proactive and meticulous Stability Scientist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

Bachelors or masters degree in chemistry Microbiology Biology Biochemistry Pharmaceutical Sciences or related field.
5 years experience in pharmaceutical QC stability or analytical development.
Experience with stability chambers and environmental monitoring
Experience with vaccine manufacture

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

Laboratory and analytical methodology experience
Prior experience in execution and control of stability trials
Advanced knowledge of stability testing guidelines
Understanding Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies processes and objectives
Strong understanding of:
- ICH stability guidelines
- cGMP requirements
- Analytical methods
- Data integrity standards

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

Develop and execute stability protocols for drug substances intermediates and finished products (ICH Q1AQ1F).
Define study parameters such as time points storage conditions sample quantities and testing requirements.
Set up stability studies to support:
- New product development
- Process validation/PPQ
- Ongoing commercial batches
- Postapproval changes (CMC changes)
Annual stability commitments.
Manage stability forum.
Manage team ensuring stability program and due dates are adhered to.
Support regulatory affairs with SAHPRA submissions.
Prepare stability reports.
Assist with OOS stability investigations.
Adhere to GMP quality systems and procedures.
Custodian of all stability protocols.
Identify gaps in current policies and procedures and propose changes or improvements to processes tools and techniques.
Perform duties as reasonably required within your scope of practice.
Remain current with all product behavior studies.

Application Deadline: 13 March 2026

If you do not receive a response from us within three weeks of submitting your application please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying you acknowledge and consent to the collection use and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns our Human Capital department is available to provide clarification. We look forward to reviewing your application.

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa with our core purpose being to protect life. We are looking to hire a dynamic passionate confident proactive and meticulous Stability Scientist to join a goal-oriented team. QUALIFICATIONS NEEDED: Bachelors or masters degree...