Senior Process Development Scientist - Biologics

Placements24

Bloemfontein

On-site

ZAR 1,000,000 - 1,700,000

Full time

3 days ago
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Benefits offered by this job

Competitive salary
Medical aid
Retirement fund
Performance bonuses
Professional development

Job summary

Placements24 in Bloemfontein, Free State, seeks a Senior Process Development Scientist specializing in biologics to drive robust, scalable manufacturing processes. You will lead projects across upstream and downstream development, characterization, and technology transfer, with a strong foundation in molecular biology and biochemistry.

The ideal candidate has hands-on bioprocess experience, GMP knowledge, and excellent problem-solving and communication skills to collaborate with cross-functional

Qualifications

  • PhD or MSc in Biochemical Engineering or related field.
  • Minimum of 5 years in biologics process development.
  • Experience with upstream and/or downstream unit operations.
  • GMP knowledge and regulatory documentation experience.

Responsibilities

  • Design and optimize upstream and/or downstream processes for biologics manufacturing.
  • Characterize process performance and product quality attributes.
  • Develop and validate analytical methods to support development.
  • Lead technology transfer activities to manufacturing sites.
  • Troubleshoot technical issues during development and manufacturing.
  • Prepare detailed technical reports and regulatory documents.
  • Collaborate with analytical development, manufacturing, QA and regulatory teams.
  • Stay current with industry trends and best practices in bioprocess development.

Skills

Biochemical Engineering
Molecular Biology
Bioprocess Development
Analytical Skills
Regulatory Awareness

Education

PhD in Biochemical Engineering
Master's in Biochemical Engineering

Tools

HPLC
Mass Spectrometry
SDS-PAGE
ELISA
JMP
Minitab

Job description

About the Role

Our client, a leading biopharmaceutical company, is seeking an accomplished Senior Process Development Scientist specializing in biologics to join their innovative team in Bloemfontein, Free State . This role is central to the development and optimization of robust, scalable, and cost-effective manufacturing processes for complex biologic drug substances. You will lead critical projects focused on upstream and/or downstream process development, characterization, and technology transfer. The ideal candidate will possess a strong scientific background in molecular biology, biochemistry, or biochemical engineering, coupled with hands-on experience in bioprocess development. This is a fantastic opportunity to contribute to the advancement of life-saving biologic therapies.

Key Responsibilities
  • Design and execute experiments to develop, optimize, and scale-up upstream and/or downstream processes for biologics manufacturing (e.g., cell culture, chromatography, filtration).
  • Characterize process performance and product quality attributes using relevant analytical techniques.
  • Develop and validate analytical methods to support process development and control strategies.
  • Lead technology transfer activities for new processes to manufacturing sites.
  • Troubleshoot and resolve technical issues encountered during process development and manufacturing.
  • Prepare detailed technical reports, development protocols, and regulatory documents.
  • Collaborate effectively with cross-functional teams including analytical development, manufacturing, quality control, and regulatory affairs.
  • Stay current with industry trends, new technologies, and best practices in bioprocess development.
Requirements
  • Ph.D. or Master's degree in Biochemical Engineering, Chemical Engineering, Molecular Biology, Biochemistry, or a related field.
  • Minimum of 5 years of relevant experience in process development for biologics (e.g., monoclonal antibodies, recombinant proteins, vaccines).
  • Hands-on experience with key bioprocessing unit operations (e.g., bioreactors, harvest, chromatography, TFF).
  • Proficiency in analytical techniques commonly used for biologics characterization (e.g., HPLC, SDS-PAGE, ELISA, mass spectrometry).
  • Strong understanding of GMP principles and regulatory requirements for biologics manufacturing.
  • Excellent problem-solving, critical thinking, and experimental design skills.
  • Strong written and verbal communication skills, with the ability to present complex technical information effectively.
  • Experience with statistical analysis software (e.g., JMP, Minitab) is desirable.
Benefits

Our client provides a competitive salary and a comprehensive benefits package, including medical aid, retirement fund contributions, and performance bonuses. Professional development opportunities, including training and conference attendance, are actively supported. This role is based in Bloemfontein, Free State , offering a chance to work in a cutting-edge biopharmaceutical environment.

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