Biologics Manufacturing Specialist

Placements24; Soweto; On-site; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Health and wellness benefits

Retirement savings plan

Performance-based bonuses

Professional development and career-op

Job summary

Placements24 in Soweto, Gauteng, seeks a Biologics Manufacturing Specialist to oversee upstream and downstream operations, ensuring GMP compliance, aseptic technique, and precise batch-record documentation to support the production of life-saving biologic therapies.

The role requires hands-on mammalian cell culture, bioreactor operations, chromatography, and filtration, with strong data integrity and teamwork. Flexibility for shifts may be needed to meet production schedules.

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Microbiology, or related field.
• Minimum 3 years hands-on biologics manufacturing experience.
• Strong aseptic technique and mammalian cell culture proficiency.

Responsibilities

• Operate upstream (cell culture) and downstream (purification) manufacturing equipment.
• Perform cell culture operations including inoculum preparation and bioreactor seeding.
• Conduct protein purification via chromatography and filtration.
• Adhere to Batch Records and SOPs; document all manufacturing activities.
• Monitor process parameters and environmental conditions to ensure quality.
• Perform in-process testing and sampling as required.
• Participate in deviation investigations, change controls, and CAPA.
• Ensure GMP compliance and safety regulations.
• Assist in equipment cleaning, maintenance, and calibration.
• Contribute to process improvement initiatives.

Skills

Aseptic techniques

Mammalian cell culture

Chromatography

Filtration

Protein purification

GMP compliance

Documentation

Problem solving

Communication

Flexibility

Education

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Microbiology, or related field

Job description

About the Role

Our client, a rapidly growing biopharmaceutical company, is seeking a skilled and motivated Biologics Manufacturing Specialist to join their advanced manufacturing facility in Soweto, Gauteng . This role is crucial for the successful production of life-saving biologic therapies. You will be involved in various stages of cell culture, purification, and downstream processing, ensuring adherence to strict GMP standards and aseptic techniques. The ideal candidate will have a strong understanding of mammalian cell culture, bioreactor operations, and protein purification techniques. This is a fantastic opportunity to contribute to the production of critical medicines within a supportive and dynamic team in Soweto . The facility is equipped with state-of-the-art technology for biologic drug manufacturing.

Key Responsibilities

• Operate and maintain upstream (cell culture) and downstream (purification) manufacturing equipment.
• Perform cell culture operations, including inoculum preparation, bioreactor seeding, and monitoring.
• Conduct protein purification processes using techniques such as chromatography and filtration.
• Execute manufacturing processes according to approved Batch Records and Standard Operating Procedures (SOPs).
• Monitor critical process parameters and environmental conditions to ensure product quality and process integrity.
• Perform in-process testing and sampling as required.
• Document all manufacturing activities accurately and contemporaneously in batch records.
• Participate in deviation investigations, change controls, and CAPA implementation.
• Ensure compliance with Good Manufacturing Practices (GMP) and all applicable safety regulations.
• Assist in equipment cleaning, maintenance, and calibration activities.
• Contribute to process improvement initiatives and optimization efforts.

Requirements

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Microbiology, or a related scientific field.
• Minimum of 3 years of hands-on experience in biologics manufacturing, preferably in upstream or downstream processing.
• Proficiency in aseptic techniques and mammalian cell culture is essential.
• Experience with chromatography, filtration, and other protein purification methods.
• Understanding of Good Manufacturing Practices (GMP) and regulatory requirements for biologic products.
• Ability to interpret and follow complex technical procedures and Batch Records.
• Strong attention to detail and commitment to data accuracy and quality.
• Good problem-solving and troubleshooting skills.
• Effective communication and teamwork abilities.
• Willingness to work flexible hours, including shifts and occasional weekends, as required by production schedules.

Benefits

• Our client offers a competitive salary, comprehensive health and wellness benefits, retirement savings plan, and potential for performance-based bonuses.
• Opportunities for professional development, specialized training, and career advancement within a growing biopharmaceutical company are provided.
• Employees are part of an innovative and collaborative work environment.

Join our team in Soweto, Gauteng , and play a vital role in producing essential biologic therapies.