AMD Chemistry Senior Scientist at Biovac

About the job:

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 AMD Chemistry Senior Scientist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Preferably PhD or MSc with at least 1-2 years experience in relevant discipline.
• or equivalent industry experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 2 Years experience in vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
• 1 Year supervisory experience in product development or a cGMP environment.
• Exposure and understanding of scientific principles that governs production of vaccines and /or biologicals.
• Quality & regulatory compliance knowledge, i.e. SAPHRA and WHO.
• GDP and IP management knowledge preferable.
• Experience in technology transfer would be advantageous.
• Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines.
• Experience in having faced successfully local quality audits would be an advantage.
• Exposure to the development and commercialisation of a pharmaceutical product.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• 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/Scientist to identify anticipated risks impacting group/ unit/ team.
• Follow cGMP guidelines and ensure all Change Controls/ NCRs etc, are effectively managed to support QAs 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 analytical method development (chemical).
• Responsible for experimental design, planning, execution, problem solving and recording.
• Accountable for specified deliverables within projects according to agreed timelines.
• 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.
• Driving Quality Risk Management.
• Managing Deviations, Change Controls, CAPAs.
• Quality Objectives: Drive the quality objectives.
• Communication:
• Ensure a timely and effective communication.
• Escalate quality issues to the appropriate levels of management.