R&d Executive

2 weeks ago

Khopoli, India Kopran Ltd Full time

a role responsible for transferring critical technical knowledge, including manufacturing processes, analytical methods, and product specifications, from one location (like R&D) to another (like a manufacturing site) to ensure consistent and compliant production of a drug product, adhering to regulatory guidelines and quality standards; essentially acting as a bridge between development and manufacturing teams to facilitate seamless product launch and commercialization. Key responsibilities of a Tech Transfer specialist in pharma might include:

- **Process transfer**:Detailed documentation and transfer of manufacturing processes from development scale to commercial scale, including scale-up activities and optimization.
- **Analytical method transfer**:Transferring analytical methods used for quality control testing from development to manufacturing, ensuring accuracy and precision of assays.
- **Documentation and regulatory compliance**:Preparing comprehensive technology transfer documentation, ensuring compliance with relevant regulatory standards (like ICH guidelines).
- **Site qualification and validation**:Supporting the qualification and validation activities at the receiving manufacturing site.
- **Training and knowledge sharing**:Providing technical training to manufacturing personnel on new processes and procedures.
- **Troubleshooting and problem-solving**:Identifying and resolving technical issues arising during technology transfer process.
- **Project management**:Managing the technology transfer timeline, budget, and deliverables.
- **Communication and collaboration**:Collaborating effectively with cross-functional teams across R&D, manufacturing, quality assurance, and regulatory affairs.

Required skills and qualifications:

- **Scientific background**:Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or related field.
- **Technical expertise**:Thorough understanding of pharmaceutical manufacturing processes, analytical methods, and regulatory requirements.
- **Experience in drug development**:Experience in different stages of drug development, including pre-clinical, clinical, and commercialization.
- **GMP knowledge**:Strong understanding of Good Manufacturing Practices (GMP) guidelines and quality standards.
- **Project management skills**:Ability to plan, execute, and monitor technology transfer projects effectively.
- **Communication skills**:Excellent written and verbal communication skills to effectively communicate technical information to diverse stakeholders.

**Job Types**: Full-time, Fresher

Pay: ₹20,000.00 - ₹35,988.49 per month

**Benefits**:

- Health insurance
- Provident Fund

Shift:

- Day shift
- Evening shift
- Rotational shift

**Experience**:

- Tech Transfer R&D: 1 year (required)

Work Location: In person

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