Senior Manufacturing Specialist

Job Responsibilities:

• Execute gene therapy manufacturing processes according to established protocols and standard operating procedures (SOPs).
• Perform cell culture, transfection, purification, and other molecular biology techniques involved in gene therapy production.
• Operate and maintain equipment such as bioreactors, chromatography systems, and filtration units used in gene therapy manufacturing.
• Monitor and control critical process parameters to ensure product quality and yield meet specifications.
• Participate in process troubleshooting and resolution of manufacturing deviations or discrepancies.
• Contribute to the design and optimization of manufacturing processes to enhance efficiency and scalability.
• Document manufacturing activities, including batch records, logbooks, and equipment maintenance records, in compliance with regulatory requirements.
• Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Process Development, and Engineering, to achieve production goals and maintain compliance.

Qualifications:

• Bachelor's degree in Biochemistry, Molecular Biology, Biotechnology, or a related field preferred.
• Minimum of 1-5 years of experience in biopharmaceutical manufacturing, preferably in gene therapy or viral vector production.
• Hands-on experience with cell culture techniques, viral vector production, and purification processes.
• Proficiency in operating and troubleshooting bioprocessing equipment such as bioreactors, centrifuges, and chromatography systems.
• Strong understanding of cGMP regulations and guidelines governing biopharmaceutical manufacturing.
• Excellent analytical and problem-solving skills, with the ability to troubleshoot process issues and implement solutions.
• Effective communication skills and the ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with a focus on accuracy and compliance in documentation and record-keeping.
• Ability to adapt to a fast-paced and dynamic work environment, with a commitment to continuous learning and improvement.