AMD Immunology Senior Scientist

Biovac

Cape Town, Western Cape
Permanent
Full-time

25 days ago
Apply easily

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 Immunology 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 (microbial and immunological).
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:
o Ensure a timely and effective communication.
o Escalate quality issues to the appropriate levels of management.

Application Deadline: 10 April 2024Disclaimer: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