Research Scientist

Design, execute, and optimize protein purification protocols using chromatography (affinity, ion exchange, size exclusion), ultrafiltration/diafiltration, and other downstream techniques.
Develop scalable purification methods to facilitate the transfer of processes from research to manufacturing.
Conduct experiments aimed at improving yield, purity, and cost-efficiency while adhering to regulatory standards.
Ensure all purification processes comply with GMP regulations, including validation of procedures, equipment, and critical process parameters.
Maintain accurate and detailed records of experiments, process development activities, and data analysis per regulatory requirements.
Author technical reports, protocols, and batch records for internal and external regulatory submissions.
Collaborate with analytical teams to assess product purity, stability, and performance using techniques such as SDS-PAGE, HPLC, mass spectrometry, and spectrophotometry.
Troubleshoot and resolve analytical challenges associated with purification processes.
Partner with manufacturing teams to scale up purification processes from laboratory to pilot and production scales.
Develop and provide detailed process transfer documentation for seamless integration into GMP manufacturing environments.
Assist in the qualification and validation of purification equipment, including chromatography columns, filtration systems, and pumps.
Conduct validation studies to ensure consistent, reproducible results in compliance with regulatory standards.
Work closely with upstream process development, quality assurance, and manufacturing teams to align purification processes with overall production goals.
Provide technical expertise, guidance, and mentorship to junior staff and technicians in protein purification methods.
Stay updated with advancements in purification technologies and GMP regulatory guidelines.
Identify and implement innovative solutions to enhance process efficiency, yield, and compliance.

Desired Candidate Profile:

PhD, MSc, or BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field.

Experience:
Proven expertise in protein purification and downstream processing, with hands-on experience in chromatography and filtration techniques.
Familiarity with GMP-regulated environments and process validation practices.

Skills:
Strong analytical and problem-solving skills, with the ability to interpret complex data.
Proficiency in technical writing and documentation for regulatory purposes.
Excellent communication and teamwork skills, with experience collaborating in cross-functional teams.

Employment Type: Full Time

Company Industry:

• Medical
• Medical Devices

Department / Functional Area:

• R&D
• Research & Development

Keywords:

• Research Scientist
• Data Analysis
• Scientific Researcher
• Research Design
• Laboratory Scientist
• Scientific Writing