Senior Process Development Engineer - Biologics Manufacturing

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 1,200,000 - 2,200,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, vision insurance

Retirement savings plan

Generous paid time off

Home office setup

Tech allowance

Career development opportunities

Remote-first culture

Job summary

Placements24 is recruiting a Senior Process Development Engineer for a pioneering biopharmaceutical company. This fully remote role focuses on designing, optimizing, and scaling biologics manufacturing processes from home.

You will work across upstream and downstream operations, process validation, and technology transfer to enable robust, compliant production. The ideal candidate has 5+ years in biologics process development, strong problem-solving, excellent communication, and experience with

Qualifications

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Minimum of 5 years of experience in process development for biologics.
• Strong experience in upstream or downstream processing and scale-up.
• Knowledge of process validation and cGMP manufacturing environments.
• Proficiency in data analysis software (JMP, Minitab).
• Excellent problem-solving and communication skills.
• Ability to work independently in a remote setting.
• Familiarity with QbD principles is a plus.

Responsibilities

• Develop and optimize cell culture (upstream) or protein purification (downstream) processes for biologics.
• Design and execute experiments to characterize and improve process performance.
• Perform process scale-up activities from lab to pilot and commercial scales.
• Develop and execute process validation strategies and protocols.
• Troubleshoot and resolve complex technical issues related to bioprocesses.
• Author technical reports, process descriptions, and tech transfer documentation.
• Collaborate with analytical development, quality control, and manufacturing teams.
• Stay updated on new technologies and best practices in bioprocess development.
• Ensure all activities comply with cGMP regulations and SOPs.

Skills

Bioprocessing

Data analysis

Problem solving

Remote work

Education

Master's or PhD in Chemical/Biochemical Engineering or Biotechnology

Tools

JMP

Minitab

Job description

About the Role

Our client, a pioneering biopharmaceutical company, is seeking a highly skilled Senior Process Development Engineer to join their advanced manufacturing team. This role operates on a fully remote basis, allowing you to contribute your expertise to critical bioprocess development initiatives from your home office. You will be instrumental in designing, optimizing, and scaling up manufacturing processes for biologic drug substances. This position requires a deep understanding of upstream and/or downstream bioprocessing, process validation, and technology transfer. The ideal candidate is a proactive problem-solver with a strong background in biological process engineering and a commitment to innovation. This is an exceptional opportunity to work with cutting-edge technologies in a remote-first environment, collaborating with a world-class team dedicated to bringing life-changing biologic therapies to patients. Your technical acumen will drive efficiency and success in our manufacturing operations.

Key Responsibilities

• Develop and optimize cell culture (upstream) or protein purification (downstream) processes for biologics manufacturing.
• Design and execute experiments to characterize and improve process performance, yield, and product quality.
• Perform process scale-up activities from laboratory to pilot and commercial scales.
• Develop and execute process validation strategies and protocols.
• Troubleshoot and resolve complex technical issues related to bioprocesses.
• Author technical reports, process descriptions, and technology transfer documentation.
• Collaborate with analytical development, quality control, and manufacturing teams to ensure seamless process implementation.
• Stay abreast of new technologies and industry best practices in bioprocess development.
• Ensure all activities comply with cGMP regulations and internal SOPs.

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 5 years of experience in process development for biologics (e.g., monoclonal antibodies, recombinant proteins).
• Strong experience in upstream (e.g., bioreactor operation, cell culture media optimization) or downstream (e.g., chromatography, filtration) processing.
• Knowledge of process validation, scale-up principles, and cGMP manufacturing environments.
• Proficiency in data analysis and statistical software (e.g., JMP, Minitab).
• Excellent problem-solving and analytical skills.
• Strong written and verbal communication skills, with the ability to present technical information clearly.
• Proven ability to work independently and manage projects effectively in a remote setting.
• Familiarity with QbD principles and process modeling is a plus.

Benefits

• Competitive salary and bonus structure.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan.
• Generous paid time off and holidays.
• Home office setup and technology allowance.
• Significant opportunities for career advancement and professional development.
• Engage in cutting-edge biopharmaceutical manufacturing research.
• Full remote work flexibility.