Process Development Scientist

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.

Roles & Responsibilities

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

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Experience in process optimization, development and troubleshooting in relevant dosage forms or technologies
• Hands-on experience in end-to-end scale up
• Depth understanding of process techniques & equipment knowledge
• Knowledge on Deficiency management and product validations.
• Experience in manufacturing process improvement.
• Experience with oral solid formulations.

BehavioralSkills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building, leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams.