Process Development Scientist - Biologics

Placements24; Bloemfontein; Híbrido; ZAR 900.000 - 1.600.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote-first role

Competitive salary

Health, dental & vision insurance

Professional growth opportunities

Descripción de la vacante

Placements24 is seeking a Process Development Scientist with expertise in biologics to join a remote team focused on developing, optimizing, and scaling up manufacturing processes for biologic drug substances. The role emphasizes cell culture, downstream purification, DoE, and regulatory support.

The ideal candidate holds a Ph.D. in a related field, with at least five years of industry experience in biologics process development, and can work effectively in a remote-first environment across

Formación

• PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Minimum 5 years of industry experience in biologics process development.
• Extensive experience with mammalian cell culture and purification techniques.

Responsabilidades

• Develop and optimize upstream (cell culture) and/or downstream (purification) processes for biologic drug substances.
• Design and execute DoE studies to evaluate process parameters and identify CPCs.
• Perform process characterization studies to ensure robustness and scalability.
• Utilize DoE and process modeling tools to optimize processes.
• Troubleshoot and resolve technical challenges during development and scale-up.
• Author technical reports, development protocols, and sections of regulatory submissions.
• Collaborate with analytical development, manufacturing sciences, and QA teams.

Conocimientos

Mammalian cell culture

Protein purification

DoE and statistical analysis

Process characterization

Remote collaboration

Educación

PhD in Chemical Engineering, Biochemical Engineering, Biotechnology

Herramientas

Bioreactors

Purification equipment

Chromatography

Filtration

Descripción del empleo

About the Role

Our client, a rapidly growing biopharmaceutical company at the forefront of innovative therapeutics, is seeking a highly skilled Process Development Scientist with expertise in biologics to join their cutting-edge team. This is a fully remote position, offering the flexibility to contribute to groundbreaking scientific advancements from your home office. You will be instrumental in developing, optimizing, and scaling up manufacturing processes for complex biologic drug substances. This role requires a deep understanding of cell culture, downstream purification, and process characterization techniques. You will collaborate with a global team of scientists and engineers, leveraging state-of-the-art technologies to ensure the robust and efficient production of high-quality biologic therapies. The ideal candidate is passionate about bioprocess engineering and possesses a strong track record of success in process development within a remote-first or hybrid environment. This opportunity allows you significantly impact the development of novel treatments for unmet medical needs.

Key Responsibilities

• Develop and optimize upstream (cell culture) and/or downstream (purification) processes for biologic drug substances (e.g., monoclonal antibodies, recombinant proteins, viral vectors).
• Design and execute laboratory-scale experiments to evaluate process parameters and identify critical process controls (CPCs).
• Perform process characterization studies to ensure robustness and scalability.
• Utilize statistical design of experiments (DoE) and process modeling tools to optimize processes.
• Troubleshoot and resolve technical challenges encountered during process development and scale-up.
• Author technical reports, development protocols, and sections of regulatory submissions.
• Collaborate effectively with analytical development, manufacturing sciences, and quality assurance teams.
• Stay abreast of emerging technologies and scientific advancements in bioprocess development.
• Contribute to technology transfer activities to internal or external manufacturing sites.
• Ensure all development activities are conducted in compliance with relevant regulatory guidelines (e.g., ICH).

Requirements

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 5 years of relevant industry experience in process development for biologics.
• Extensive experience with mammalian cell culture processes and/or protein purification techniques (e.g., chromatography, filtration).
• Proficiency in Design of Experiments (DoE) software and statistical analysis.
• Hands-on experience with laboratory-scale bioreactors and purification equipment.
• Strong understanding of molecular biology, biochemistry, and bioprocess engineering principles.
• Excellent problem-solving skills and a creative approach to scientific challenges.
• Strong written and verbal communication skills, with the ability to present complex data clearly.
• Demonstrated ability to work independently, manage projects, and collaborate effectively in a remote team setting.
• Familiarity with regulatory expectations for biologics manufacturing is a significant advantage.

Benefits

• Our client offers a highly competitive salary, comprehensive benefits package including health, dental, and vision insurance, a generous retirement plan, and significant opportunities for professional growth.
• This role is fully remote, providing exceptional flexibility and work-life balance.
• We provide necessary technology and support for remote employees to thrive.
• Paid time off includes annual leave, sick leave, and public holidays.
• Join a forward-thinking organization dedicated to advancing biologic therapies for global health.