Downstream - Expert

2 weeks ago

Gajularamaram Hyderabad Telangana, India Amogen pharma pvt ltd Full time

**Job description** - **Responsibilities**: - Results-driven Process Development Engineer with 7+ years of experience optimizing biopharmaceutical manufacturing processes. innovative continuous flow reactor design. Expert in Design of Experiments (DoE) and Process Analytical Technology (PAT),. Led cross-functional team to develop a novel green synthesis method. - Process validation, Cleaning Validation studies to ensure compliance with cGMP regulations." - "Collaborated with cross-functional teams to scale up bioprocesses from pilot to commercial manufacturing." - Troubleshooting and optimization of downstream purification processes." - Proficient in advanced process simulation software and lifecycle assessment tools, with a track record of scaling up pilot projects to full production **- Technical Skills**: - Specific equipment knowledge (e.g., bioreactors, chromatography systems, centrifuges, autoclaves, DHS, Freezedryer, filling equipment,). - Understanding of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., FDA, EMA). - Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes. - Knowledge of calibration and maintenance procedures. - Familiarity with relevant software and automation systems. - Troubleshooting and problem-solving skills related to equipment. - Understanding of validation principles and documentation. - **Soft Skills**: - Technical writing and documentation skills. - Problem-solving and analytical skills. - Communication and collaboration skills. - Organizational skills. - Ability to follow protocols and procedures. **Job Types**: Full-time, Permanent Pay: ₹25,000.00 - ₹40,000.00 per month **Benefits**: - Food provided - Health insurance - Provident Fund Schedule: - Day shift - Morning shift Work Location: In person **Job Types**: Full-time, Permanent Pay: ₹15,000.00 - ₹30,000.00 per month **Benefits**: - Food provided - Health insurance - Provident Fund Schedule: - Day shift - Morning shift Work Location: In person

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