Expert Science and Technology

Major accountabilities:

• Responsibilities for technology transfer to various internal and external manufacturing sites, which meets the quality and timelines for the projects assigned. Trouble shoot the process if needed and coordinate with various stakeholders to arrive at decision.
• Key experience in solid oral dosage form technology transfer as an individual contributor.
• Hands on experience in development of process for solid oral dosage form.
• Key expertise in wet granulation, dry granulation, compression and coating; especially in minitablets and wuster coating.
• Meet quality, quantity and timelines in all assigned projects. Ensure all own activities are aligned with overall drug development process.
• Plan, organize, perform and document scientific experiments/plant activities in collaboration with project teams and under minimal guidance from more experienced team members (eg. contribute to interpretation and report results). Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
• Provide raw data documentation, evaluation and results interpretation. Propose and provide input for the design of next experiments.
• Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team members.
• Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility.
• Collaborate with other team members to facilitate deliveries of DS and/or DP.
• Ensure all their own activities are aligned with the overall drug development process.
• Support team’s resource planning and effective resource utilization
• Support and foster strong quality/compliance mindset for own projects and overall portfolio/initiatives. Ensure internal processes as per SOPs/guidelines are followed and internal quality metrics are met. Fully support GxP and general deliverables.
• Ensure training is up-to-date and on time; no overdue training assignments without acceptable cause.
• Ensure strict adherence to HSE rules and guidelines.

Key performance indicators:

• Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

Minimum Requirements:
Bachelor's degree with 12 years of relevant experience or Master's degree with 10 plus years of relevant experience.

Work Experience:

• Hands on experience in development, Scale-up and Technology transfer of solid oral dosage forms - Tablets, mini tablets, pellets.
• Expertise in technologies for Solid Orals - High Shear wet granulation, Fluid bed granulation, Roller compaction and Compression.
• Knowledge of pediatric product development.

Skills:

• Environment.
• Experiments Design.
• Health And Safety (Ehs).
• Laboratory Equipment.
• Manufacturing Process.
• Process Simulation.
• Sop (Standard Operating Procedure).
• Technical Writing.

Languages :

• English.