About the Role
Our client, a forward-thinking biopharmaceutical company dedicated to pioneering innovative therapies, is seeking a highly skilled Biopharmaceutical Development Scientist to join their globally distributed, fully remote research team. In this critical role, you will drive the development and optimization of manufacturing processes for biologics, contributing to the scale-up and commercialization of our client's novel protein-based therapeutics. You will focus on areas such as upstream (cell culture) and downstream (purification) process development, characterization, and technology transfer. This position is ideal for a scientist who thrives in a remote work environment, possesses a strong analytical aptitude, and has a deep understanding of bioprocessing and protein chemistry. You will collaborate closely with cross-functional teams, including R&D, analytical development, quality assurance, and manufacturing, all within a virtual setting that fosters innovation and efficient problem-solving. Your expertise will be essential in ensuring the robust and scalable production of life-changing biologic medicines for patients worldwide.
Key Responsibilities
- Develop and optimize cell culture processes for mammalian cell lines to achieve high yields and desired product quality attributes.
- Design and execute purification strategies for recombinant proteins and monoclonal antibodies using various chromatography techniques.
- Characterize biopharmaceutical products to ensure identity, purity, potency, and stability.
- Perform process development studies, including DoE, to optimize critical process parameters (CPPs) and identify critical quality attributes (CQAs).
- Support technology transfer activities for processes developed in the lab to pilot plant and manufacturing sites.
- Troubleshoot process-related issues and implement corrective actions.
- Collaborate with analytical development teams to develop and validate analytical methods for product characterization.
- Contribute to the preparation of regulatory documentation (e.g., CMC sections for INDs and BLAs).
- Stay current with advancements in biopharmaceutical development, manufacturing technologies, and regulatory guidelines.
- Maintain detailed experimental records and prepare comprehensive development reports.
Requirements
- PhD in Chemical Engineering, Biochemical Engineering, Biochemistry, Molecular Biology, or a related life science discipline.
- Minimum of 5 years of experience in biopharmaceutical process development (upstream and/or downstream).
- Proven expertise in mammalian cell culture process development and/or protein purification techniques.
- Strong understanding of protein biochemistry, molecular biology, and analytical techniques for biologics characterization (e.g., HPLC, ELISA, SDS-PAGE, mass spectrometry).
- Experience with process scale-up and technology transfer is highly desirable.
- Familiarity with regulatory requirements for biologics development (e.g., ICH, FDA, EMA guidelines).
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to clearly present complex scientific data.
- Demonstrated ability to work independently and collaboratively in a fully remote team environment.
- Experience with statistical software for experimental design and data analysis is a plus.
Benefits
- Highly competitive salary package commensurate with experience and expertise.
- Fully remote working arrangement providing excellent flexibility and work-life balance.
- Significant opportunities for career advancement and professional development within a leading biopharma company.
- Direct impact on bringing novel biologic therapies to patients in need.
- Access to state-of-the-art virtual research tools and advanced scientific literature.
- Flexible working hours to support individual needs and peak productivity.
- A collaborative and innovative global scientific team.
- Comprehensive health, dental, and vision insurance coverage.