Senior Process Development Engineer - Biologics (Remote)

Placements24; Paarl; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Bonus program

Medical coverage

Dental coverage

Vision coverage

Retirement plan

Remote work

Job summary

Placements24 client, a leader in the development and manufacturing of advanced biologics, seeks a Senior Process Development Engineer for a fully remote role focused on designing, optimizing, and scaling up bioprocesses for therapeutic proteins and other biological products.

You will work from your home office, with the Paarl vicinity noted for administrative oversight within our South African structure, though your role is remote.

Qualifications

• Ph.D. or MSc in Chemical/Biochemical Engineering or related field.
• 7+ years in biopharmaceutical process development.
• Experience in scale-up and technology transfer.
• Knowledge of cell culture, fermentation, purification, and biologics formulation.
• Proficiency in process modeling software and statistics (e.g., JMP, Design-Expert).
• Excellent analytical and communication skills.
• Ability to work independently in a remote environment.
• Experience with GMP manufacturing.

Responsibilities

• Develop and optimize upstream and downstream bioprocesses for biologics (e.g., mAbs, recombinant proteins).
• Design and execute experiments to understand process parameters and CPCs, and establish design space.
• Scale-up processes from lab to pilot and commercial scales with robustness.
• Troubleshoot deviations and implement corrective actions.
• Utilize PAT and statistical tools for process monitoring and control.
• Author development reports and regulatory filing support documents.
• Collaborate with manufacturing, QA, and regulatory teams for successful implementation and validation.
• Stay current with emerging technologies and best practices in bioprocess development.
• Manage project timelines and resources in a remote setting.

Skills

Bioprocess development

Scale-up technology transfer

Process modeling

Remote collaboration

Education

Ph.D. or MSc in Chemical/Biochemical Engineering

Tools

JMP

Design-Expert

Job description

About the Role

Our client, a leader in the development and manufacturing of advanced biologics, is seeking a highly skilled Senior Process Development Engineer. This is a critical, fully remote role focused on designing, optimizing, and scaling up bioprocesses for therapeutic proteins and other biological products. You will be at the forefront of innovation, applying your expertise to ensure robust, efficient, and reproducible manufacturing processes. As a remote-first company, we champion asynchronous communication, advanced collaboration tools, and a culture of trust and autonomy, ensuring our remote team members are fully integrated and productive. This position offers an exceptional opportunity to contribute to the production of life-saving therapies from your home office. Your technical prowess will be key to our success. The Paarl vicinity is noted for administrative oversight within our client's South African structure, though your role will be performed entirely remotely.

Key Responsibilities

• Develop and optimize upstream and downstream bioprocesses for the manufacture of biologics (e.g., mAbs, recombinant proteins).
• Design and execute experiments to understand process parameters, identify critical process controls (CPCs), and establish process design space.
• Scale-up processes from laboratory to pilot and commercial manufacturing scales, ensuring process robustness and consistency.
• Troubleshoot process deviations and implement effective corrective and preventive actions.
• Utilize Process Analytical Technology (PAT) and statistical tools for process monitoring and control.
• Author development reports, technology transfer documents, and regulatory filing support documentation.
• Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure successful process implementation and validation.
• Stay current with emerging technologies and industry best practices in bioprocess development.
• Manage project timelines and resources effectively in a remote setting.

Requirements

• Ph.D. or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 7 years of experience in biopharmaceutical process development, with a strong focus on upstream or downstream processing.
• Demonstrated experience in process scale-up and technology transfer.
• In-depth knowledge of cell culture, fermentation, purification techniques, and formulation of biologics.
• Proficiency in using process modeling software and statistical analysis tools (e.g., JMP, Design-Expert).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication abilities, with experience presenting technical data.
• Proven ability to work independently, manage priorities, and collaborate effectively in a remote environment.
• Experience with GMP manufacturing environments.
• Must have a dedicated home workspace with a stable, high-speed internet connection.

Benefits

• Our client offers a highly competitive salary and a comprehensive bonus program.
• Benefits include top-tier medical, dental, and vision coverage, a generous retirement savings plan, and substantial paid time off.
• Continuous professional development opportunities, including access to training and scientific forums, are provided.
• This role offers the ultimate flexibility of working remotely.