Stability Scientist at Biovac

Cape Town, Western Cape, South Africa -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

0.0

Posted On

18 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability Protocols, ICH Guidelines, cGMP Requirements, Analytical Methods, Data Integrity, Stability Chambers, Environmental Monitoring, Vaccine Manufacture, Stability Trials, Regulatory Affairs, OOS Investigations, Quality Systems, Process Validation, CMC Changes, Chemistry, Microbiology

Industry

Pharmaceutical Manufacturing

Description

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: Bachelor's or master's 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 Q1A–Q1F). 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 Post‑approval 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.

Responsibilities

The Stability Scientist will develop and execute stability protocols for drug substances, intermediates, and finished products according to ICH guidelines, defining study parameters and managing stability studies for various purposes like new product development and ongoing commercial batches. Key duties also involve managing the stability forum, overseeing team adherence to the stability program, supporting regulatory submissions, preparing reports, and assisting with Out-of-Specification (OOS) investigations.