Biologics Manufacturing Specialist - Upstream Processing

Placements24; Stellenbosch; Hybrid; ZAR 900,000 - 1,600,000; Full time

Benefits offered by this job

Remote work

Home office stipend

Professional development budget

Paid time off

Retirement savings plan

Wellness initiatives

Job summary

Placements24 is seeking a Biologics Manufacturing Specialist to oversee upstream bioprocessing and optimize cell culture and fermentation in a fully remote role. You will drive CAPAs, process validation, and cross-functional collaboration with global teams to ensure high-quality biologics production.

The ideal candidate has a minimum of 5 years in upstream biopharma manufacturing, strong GMP knowledge, and excellent remote communication and problem-solving skills.

Qualifications

• Bachelor's or Master's degree in Biotechnology, Chemical Engineering, Biochemical Engineering, Molecular Biology, or related life science field.
• Minimum of 5 years of hands-on experience in upstream biopharmaceutical manufacturing with focus on cell culture or fermentation.
• In-depth knowledge of bioreactor operation, cell line biology, and aseptic processing.
• GMP environment experience and regulatory understanding.

Responsibilities

• Operate, monitor, and optimize upstream bioprocesses including bioreactor operations, cell culture expansion, and fermentation.
• Perform aseptic techniques and ensure sterile conditions throughout operations.
• Troubleshoot process deviations and implement CAPAs.
• Execute process validation activities and ensure GMP compliance.
• Analyze process data, identify trends, and recommend improvements to enhance yield and quality.
• Prepare batch records, SOPs, and technical reports related to upstream manufacturing.
• Collaborate with R&D, process development, QA, and supply chain remotely.
• Participate in qualification and validation of new equipment and technologies.
• Ensure adherence to safety protocols and environmental regulations.
• Contribute to continuous improvement of manufacturing processes.

Skills

Cell culture

Fermentation

Aseptic processing

GMP compliance

Data analysis

Problem solving

Remote collaboration

Education

Bachelor's or Master's in Biotechnology or related life science field

Tools

Statistical software

Job description

About the Role Our client, a pioneer in advanced biopharmaceutical manufacturing, is seeking a highly skilled Biologics Manufacturing Specialist to join their innovative and forward-thinking team. This is a fully remote position, offering unparalleled flexibility and the opportunity to contribute to cutting-edge biologics production from anywhere. You will be responsible for overseeing and optimizing upstream processes, including cell culture and fermentation, for the development and manufacturing of therapeutic proteins and antibodies. The ideal candidate will possess a deep understanding of bioprocess engineering, cell biology, and GMP environments. This role is critical in ensuring the consistent and high-quality production of life-saving biologics, working closely with global teams to advance pipeline candidates. We are looking for a proactive, technically adept individual with exceptional problem-solving skills and a commitment to scientific excellence. This remote-first role requires strong self-discipline, effective communication, and the ability to collaborate seamlessly across distances. You will leverage advanced technology and your expertise to drive efficiency and innovation in biologics manufacturing, directly impacting patient access to essential therapies.

Key Responsibilities

• Operate, monitor, and optimize upstream bioprocesses, including bioreactor operations, cell culture expansion, and fermentation.
• Perform aseptic techniques and ensure sterile conditions are maintained throughout all operations.
• Troubleshoot process deviations and implement corrective and preventive actions (CAPAs).
• Execute process validation activities and ensure compliance with GMP regulations.
• Analyze process data, identify trends, and recommend process improvements to enhance yield, quality, and efficiency.
• Prepare batch records, SOPs, and technical reports related to upstream manufacturing.
• Collaborate with cross-functional teams, including R&D, process development, quality assurance, and supply chain, remotely.
• Participate in the qualification and validation of new equipment and technologies.
• Ensure adherence to all safety protocols and environmental regulations.
• Contribute to the continuous improvement of manufacturing processes and operational excellence.

Requirements

• Bachelor's or Master's degree in Biotechnology, Chemical Engineering, Biochemical Engineering, Molecular Biology, or a related life science field.
• Minimum of 5 years of hands-on experience in upstream biopharmaceutical manufacturing, with a strong focus on cell culture or fermentation.
• In-depth knowledge of bioreactor operation, cell line biology, and aseptic processing.
• Proven experience working within a GMP environment and understanding of regulatory requirements.
• Proficiency in data analysis and interpretation, with experience in statistical software being a plus.
• Excellent problem-solving and troubleshooting skills.
• Strong written and verbal communication skills, essential for remote collaboration.
• Demonstrated ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Familiarity with process analytical technology (PAT) is advantageous.
• Experience with single-use bioreactor systems is a plus.

Benefits

• Competitive salary and comprehensive benefits package tailored for remote employees.
• Opportunity to work with a leading biopharmaceutical company on groundbreaking therapies.
• Flexible work hours and a fully remote work environment.
• Generous professional development budget for online courses and virtual conferences.
• Collaborative and supportive virtual team culture.
• Contribution to the advancement of life-saving biologics.
• Home office stipend and IT support.
• Paid time off and company holidays.
• Retirement savings plan.
• Employee wellness initiatives.