Senior Process Development Scientist - Biologics Manufacturing

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Job summary

Placements24 is seeking a Senior Process Development Scientist to join a leading biopharmaceutical team in Nelspruit. You will drive upstream/downstream process development, optimize cell culture, and lead technology transfer to pilot and manufacturing scales.

The role requires a Ph.D./Master's in a life sciences field, 6+ years in biopharma, and strong data analysis skills with JMP/Design-Expert. Hybrid work model in Mpumalanga, ZA is offered.

Qualifications

• Ph.D. or Master's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related life science discipline.
• Minimum of 6 years of experience in biopharmaceutical process development or manufacturing.
• Strong understanding of mammalian cell culture, bioreactor operation, and scale-up principles.
• Proven experience with downstream processing techniques, including chromatography, filtration, and viral clearance.
• Proficiency in process modeling, data analysis, and statistical software (e.g., JMP, Design-Expert).
• Experience with GMP environments and regulatory requirements for biopharmaceuticals.
• Excellent problem-solving, communication, and project management skills.
• Experience working in Nelspruit, Mpumalanga, ZA or willingness to relocate.
• Ability to work effectively in a fast-paced, team-oriented environment.

Responsibilities

• Lead process development activities for the upstream and/or downstream processing of biologics (e.g., monoclonal antibodies, recombinant proteins).
• Optimize cell culture conditions, media formulations, and bioreactor parameters to maximize product yield and quality.
• Develop and validate robust purification strategies, including chromatography and filtration techniques.
• Execute experiments to troubleshoot and improve existing manufacturing processes.
• Perform process characterization studies and define CPPs and CQAs.
• Translate laboratory-scale processes to pilot and manufacturing scales, ensuring seamless technology transfer.
• Analyze process data, generate technical reports, and present findings to cross-functional teams.
• Stay abreast of new technologies and industry best practices in biologics manufacturing.
• Ensure compliance with GMP and relevant regulatory guidelines.

Skills

Bioprocessing

Mammalian cell culture

Scale-up

Process development

Data analysis

JMP

Design-Expert

GMP

Education

Ph.D. or Master's in Biochemical Engineering / Chemical Engineering / Biotechnology

Tools

JMP

Design-Expert

Job description

About the Role

Our client, a leading biopharmaceutical company, is seeking a highly skilled Senior Process Development Scientist to join their innovative biologics manufacturing team. This role, based in Nelspruit, Mpumalanga, ZA, is crucial for the development, optimization, and scale-up of manufacturing processes for biotherapeutic products. You will be responsible for advancing cutting-edge bioprocessing technologies and ensuring the robust and efficient production of life-changing medicines. The position offers a unique opportunity to work in a state-of-the-art facility in Nelspruit, Mpumalanga, ZA, contributing to critical projects within the biopharmaceutical industry. The hybrid model offers a flexible approach to work, combining focused lab time with remote project management.

Key Responsibilities

• Lead process development activities for the upstream and/or downstream processing of biologics (e.g., monoclonal antibodies, recombinant proteins).
• Optimize cell culture conditions, media formulations, and bioreactor parameters to maximize product yield and quality.
• Develop and validate robust purification strategies, including chromatography and filtration techniques.
• Execute experiments to troubleshoot and improve existing manufacturing processes.
• Perform process characterization studies and define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Translate laboratory-scale processes to pilot and manufacturing scales, ensuring seamless technology transfer.
• Analyze process data, generate technical reports, and present findings to cross-functional teams.
• Stay abreast of new technologies and industry best practices in biologics manufacturing.
• Ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.

Requirements

• Ph.D. or Master's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related life science discipline.
• Minimum of 6 years of experience in biopharmaceutical process development or manufacturing.
• Strong understanding of mammalian cell culture, bioreactor operation, and scale-up principles.
• Proven experience with downstream processing techniques, including chromatography, filtration, and viral clearance.
• Proficiency in process modeling, data analysis, and statistical software (e.g., JMP, Design-Expert).
• Experience with GMP environments and regulatory requirements for biopharmaceuticals.
• Excellent problem-solving, communication, and project management skills.
• Experience working in Nelspruit, Mpumalanga, ZA or willingness to relocate.
• Ability to work effectively in a fast-paced, team-oriented environment.

Benefits

Our client offers a highly competitive salary, comprehensive health, dental, and vision insurance, retirement savings plans, and generous paid time off. Employees benefit from access to advanced bioprocessing equipment and facilities in Nelspruit, Mpumalanga, ZA. The company is committed to employee development, offering training programs and career advancement opportunities.

Join a leading organization dedicated to improving global health through innovative biopharmaceutical manufacturing.