Downstream Expert

3 days ago

Madhapur Hyderabad Telangana, India Amogen Pharma Private Limited Full time

**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

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