Process Development Lab - (OSD) - Research Associate

Intas; Ahmedabad District; On-site; INR 6,00,000 - 10,00,000; Full time

Job summary

A leading pharmaceutical company is looking for a Specialist in Process Development. This role involves conducting evaluations to optimize processes, calculating batch sizes, and preparing technical documentation. Candidates should have experience in pharmaceutical development and be familiar with regulatory guidelines. The position is based in Ahmedabad, India.

Benefits

As per company norms

Qualifications

• Experience in pharmaceutical development processes.
• Proven ability to design and optimize processes.
• Familiarity with regulatory guidelines and industry trends.

Responsibilities

• Conduct strategy evaluations to design pharmaceutical processes.
• Calculate batch sizes for production.
• Perform scale-up calculations and manage transition processes.
• Prepare technical documentation and regulatory filings.
• Collaborate with teams for process improvements.

Skills

Pharmaceutical process optimization

Scale-up calculations

Technical documentation

Cross-functional collaboration

Regulatory compliance

Job description

Role & responsibilities

1. You will be responsible to Conduct strategy evaluations to design and optimize pharmaceutical processes, ensuring efficient and cost-effective development.
2. You will be responsible to Calculate batch sizes for both early development and commercial production, considering critical parameters and quality standards.
3. You will be responsible to Perform scale-up calculations and execute scale-up processes to ensure successful transition from lab-scale to production-scale.
4. You will be responsible to Handle exhibit batches, coordinating activities and documentation to meet regulatory requirements and project timelines.
5. You will be responsible to Prepare and maintain technical documentation, including development reports, process validation protocols, and regulatory filings.
6. You will be responsible to Collaborate with cross-functional teams to drive process improvements, troubleshoot issues, and ensure product quality and consistency.
7. You will be responsible to Stay updated with industry trends and regulatory guidelines, incorporating best practices and innovative technologies into the development process.

Preferred candidate profile

We are seeking a dynamic and experienced Specialist in Process Development in the pharmaceutical development process, responsible for strategy evaluations, process design, optimization, scale-up calculations, and handling exhibit batches. This role involves working on oral solid formulations and technical documentation, as well as process validations, to ensure the successful development and scale-up of pharmaceutical products.

Perks and benefits

As per company norms