Biovac

Manager: Microbiology and Environmental

Biovac  •  Cape Town, ZA (Onsite)  •  2 hours ago
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Job 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 Manager: Microbiology & Environmental to join a goal-oriented team

QUALIFICATIONS NEEDED:

Required:

  • Bachelor's or Master's degree in Microbiology, Biochemistry, Biotechnology, Molecular Biology, Biochemistry, or related field

Preferred:

  • Postgraduate in related field

Experience needed to deliver the role seamlessly:

Required:

  • At least 6 years' experience in vaccine / pharmaceutical / biotech manufacturing industry.
  • At least 3 years' experience at junior to middle management level.
  • Previous experience having worked in a pharmaceutical laboratory within the Microbiology or sterile divisions
  • Experience in quality and regulatory compliance within a cGMP facility
  • Strong technical Microbiology knowledge and application
  • Business and operational planning.
  • Program and project management
  • Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.

Preferred:

  • Working with knowledge of cGMP and Good Microbiology Practices
  • Experience in aseptic (sterile) manufacturing and quality control
  • Experience in having faced successfully local and/ or international quality audits.
  • Experience in general business management within a commercial environment

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery

  • Full Management oversight of all Microbiology testing activities.
  • Contribute to the Contamination Control strategy (CCS) of the site and provide Microbiology guidance to the CCS team
  • Management of the electronic Environmental Monitoring program and digital system
  • Introduction of new Microbial methods and techniques to the laboratory
  • Plan, Track and execute all QC activities related to your team to ensure successful completion within agreed timelines.
  • Set overall objectives and measurements for direct reports that is aligned to the company overall goals.
  • Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies in order to proactively manage risk, reduce wastage and to improve quality on site.
  • Reviews and Monitoring materials for reduced testing.
  • Ensures that all monthly, quarterly and annual compliance reports are completed, reviewed and approved on time.
  • Selection and procurement of Microbiology test equipment and participation in equipment qualification e.g. review of qualification documents.
  • Assist with writing and updating of material and product specifications and test methods and standard operating procedures.
  • Liaison with suppliers on technical issues where applicable.
  • Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
  • Ensure that relevant testing is performed according to the Biovac Stability Program. Assist with the compilation of stability protocols and reports.
  • Participation in quality audits and closing any gaps of findings.
  • Ensure that OOS and OOT investigations are initiated and completed to the correct standard.
  • Data integrity and access to systems are controlled
  • Identify and / or participate in inspections, investigations, risk management and quality review exercises
  • Ensures the laboratory training program is maintained and compliant to SOPs and guidelines.
  • Continuous compliance of in-process activities to quality systems, procedures and regulatory requirements
  • Track and maintain QC activities for Deviations, Change control/requests, CAPA, OOS/OOT
  • Involved in setting budgets and capex.
  • Ensure budgets are managed accordingly.
  • Compile ad hoc reports when required.
  • Lead QC decision‑making during critical quality events impacting batch disposition, supply continuity, or regulatory commitments.

People Management

  • Align departmental focus areas and outputs to the business's objectives
  • Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.
  • Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans
  • Role profiling, goal setting and performance management of managers and staff within the department.
  • Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained
  • Growth, succession & retention of departmental talent.
  • Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the department
  • Ensure accurate delegation of ongoing operational activities in the event of key staff members' absence.
  • Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.

Data Integrity Compliance

  • Ensure all laboratory data is recorded, reviewed, and stored in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
  • Promote a culture of data integrity by training staff on proper documentation practices and electronic data handling.
  • Monitor and audit data management systems to detect and prevent data manipulation, omissions, or unauthorized access.
  • Support implementation of secure, validated systems for electronic records and signatures in compliance with 21 CFR Part 11 and other applicable regulations.

Application Deadline: 30 June 2026

If you do not receive a response from us within three weeks after closing date, please understand that your application was not successful.

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.''

For detailed information on data handling, please review our privacy notice:

https://www.biovac.co.za/wp-content/uploads/2022/08/published_Biovac-Privacy-Notice-20220617-2306-en.pdf

Biovac

About Biovac

Biovac was founded in 2003 to revive and restore South Africa’s vaccine manufacturing capabilities. We are an African based manufacturer contributing towards filling the gap that exists in the lack of African vaccine manufacturing capability.

We recognise that we’ll only achieve this if we match scientific innovation through local biotechnology skills with the most advanced manufacturing technology and global partnerships. We work closely with local academic institutions, global pharmaceutical companies, the public sector as well as private sector. Some of our achievements are described below:

We manufacture highly advanced vaccines on behalf of leading international biopharmaceutical companies. Biovac is licensed to manufacture a fully liquid hexavalent vaccine from Sanofi that targets and protects against six childhood diseases. In 2021, we envisage to start the manufacture of a multivalent pneumococcal conjugate vaccine from Pfizer.

We supply over 15-million doses of vaccines a year in South Africa and neighbouring countries under strict cold chain conditions.

We have built inhouse product development capability and technologies and have successfully out-licensed one of our technologies to international manufacturers. We are working to establish new safeguards against pathogens like group B streptococcus bacteria, a rising cause of sepsis and meningitis in newborns.

To do this vital work, we rely on sophisticated technology and, above all, the skills and dedication of more than 350 highly trained team members. Along with our partners, we’ve invested over R800 million in infrastructure and skills development at our manufacturing facilities in Cape Town. These investments are resulting in estimated benefits of more than R500-million a year to the national economy.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
Cape Town, ZA
Year Founded
2003
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