Job Description

Job Summary: The Downstream Manufacturing Specialist is responsible for executing and monitoring downstream processing activities to ensure the efficient and compliant production of pharmaceutical products. This role involves operating and maintaining equipment used in purification and recovery processes following upstream bioprocessing.

Key Responsibilities:

• Downstream Processing: Execute purification and recovery operations according to Standard Operating Procedures (SOPs) and batch records. This includes chromatography, filtration, centrifugation, and other separation techniques.
• Equipment Operation: Operate and maintain downstream processing equipment such as chromatography columns, filtration systems, and centrifuges. Perform equipment set-up, cleaning, and maintenance activities to ensure proper functioning.
• Process Monitoring: Monitor process parameters and conditions during downstream operations. Conduct in-process testing and analysis to ensure product quality and yield targets are met.
• Documentation and Compliance: Maintain accurate documentation of all activities in batch records, logbooks, and electronic systems. Ensure compliance with regulatory requirements (e.g., FDA, EMA) and Good Manufacturing Practices (cGMP).
• Troubleshooting: Identify and troubleshoot issues related to downstream processes, equipment, or product quality deviations. Implement corrective and preventive actions (CAPAs) as needed.
• Quality and Safety: Adhere to safety protocols and quality standards during all manufacturing activities. Participate in audits, inspections, and investigations as required.

Required Qualifications:

• Bachelor's degree in Biochemistry, Chemical Engineering, Biotechnology, or related field. Advanced degrees (e.g., Master's or PhD) may be preferred for senior roles.
• Previous experience in downstream processing within the pharmaceutical or biotechnology industry. Familiarity with biopharmaceutical production processes is highly desirable.
• Strong understanding of cGMP regulations and industry standards for pharmaceutical manufacturing.
• Proficiency in operating and troubleshooting downstream processing equipment.
• Excellent analytical skills and attention to detail.

Effective communication skills and ability to work in a team-oriented environment

Job Types: Full-time, Permanent

Pay: ?20,000.00 - ?50,000.00 per month

Benefits:

• Food provided
• Paid sick time
• Provident Fund

Schedule:

• Day shift
• Morning shift

Experience:

• downstream: 3 years (Required)

Work Location: In person