Biopharmaceutical Process Development Scientist

Placements24; United States; Remote; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health benefits

Generous PTO

Remote-first position

Home office stipend

Professional development

Zusammenfassung

Placements24 is seeking a Biopharmaceutical Process Development Scientist for a fully remote role. The candidate will design, optimize, and scale biologics manufacturing processes, leveraging cell culture, fermentation, purification, and analytics to deliver robust processes for monoclonal antibodies and recombinant proteins.

The role requires a PhD or MSc in a related field, 5+ years of hands-on experience, and strong knowledge of QbD and regulatory expectations.

Qualifikationen

• PhD or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Minimum of 5 years of hands-on experience in biopharmaceutical process development.
• Expertise in mammalian cell culture, microbial fermentation, protein purification, or analytical characterization of biologics.
• Strong understanding of Quality by Design (QbD) principles and process validation.
• Proven ability to work independently and manage projects in a remote setting.

Aufgaben

• Develop and optimize upstream (cell culture/fermentation) and downstream (purification) processes for biologics.
• Define CPPs and CQAs through experiments.
• Use analytical techniques for process monitoring and product characterization (HPLC, ELISA, SDS-PAGE, MS).
• Perform process validation studies and technology transfer to manufacturing sites.
• Troubleshoot process issues and implement corrective actions.
• Collaborate with R&D, manufacturing, QC/QA in a virtual environment.
• Stay updated on advancements in biopharmaceutical process development.

Kenntnisse

Biopharmaceutical process development

Cell culture

Fermentation

Protein purification

Analytical characterization

Quality by Design

Regulatory awareness

Ausbildung

PhD or MSc in Chemical/Biochemical Engineering or Biotechnology

Tools

HPLC

Mass spectrometry

ELISA

Jobbeschreibung

About the Role

Our client, a cutting-edge biopharmaceutical company dedicated to developing novel therapeutics, is seeking a highly skilled Biopharmaceutical Process Development Scientist for a fully remote position. This role is crucial for the design, optimization, and scale-up of manufacturing processes for biologics, including monoclonal antibodies and recombinant proteins. The scientist will leverage deep expertise in cell culture, fermentation, purification, and analytical characterization to ensure robust and scalable processes. This is a remote-first opportunity, perfect for an individual who thrives on independent research and collaborative virtual teamwork, contributing to life-changing medicines from anywhere in South Africa.

Key Responsibilities

• Develop and optimize upstream (cell culture/fermentation) and downstream (purification) processes for biopharmaceutical products.
• Conduct experiments to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Utilize various analytical techniques for process monitoring and product characterization (e.g., HPLC, ELISA, SDS-PAGE, mass spectrometry).
• Perform process validation studies and technology transfer activities to manufacturing sites.
• Troubleshoot process issues and implement corrective actions.
• Collaborate closely with R&D, manufacturing, quality control, and quality assurance teams in a virtual environment.
• Stay abreast of the latest advancements in biopharmaceutical process development and manufacturing technologies.
• Author technical reports, protocols, and presentations for internal stakeholders and regulatory submissions.

Requirements

• PhD or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 5 years of hands-on experience in biopharmaceutical process development.
• Expertise in mammalian cell culture, microbial fermentation, protein purification, or analytical characterization of biologics.
• Strong understanding of Quality by Design (QbD) principles and process validation.
• Proven ability to work independently and manage projects effectively in a remote setting.
• Excellent problem-solving, data analysis, and critical thinking skills.
• Strong written and verbal communication skills, with experience authoring scientific documents.
• Proficiency with common bioprocessing software and analytical data systems.
• Experience with regulatory requirements for biologics (e.g., SAHPRA, FDA, EMA) is a plus.

Benefits

• Highly competitive salary commensurate with experience.
• Comprehensive health and wellness benefits package.
• Generous paid time off and flexible remote work schedule.
• Allowance for home office setup and continuous professional development.
• Opportunity to work on groundbreaking biopharmaceutical projects.
• Be part of an innovative and forward-thinking company culture.