Team Member Process Development

We are seeking a dynamic and experienced person in Process Development Plan and execute process optimization trials & to execute scale up/ confirmatory batch and to support pilot batch, exhibit batches by applying various engineering concepts during optimization and scale up.

Roles & Responsibilities

• You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and technology transfer.
• You will be responsible to demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time.
• You will be responsible to prepare documents required for confirmatory/ scale up batch at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Exhibit Batches based on Confirmation Batch (CB) results.
• You will be responsible to prepare Process optimization report & filing documents.
• You will be responsible to analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies.
• You will be responsible to develop process capabilities within team, train new joinee /freshers. Willingness to imbibe young talent and support in the initial stages.

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Experience in the development/ scale up/ technology transfer of products in relevant dosage forms or technologies.
• Understanding of pharmaceutical process selection
• Ability to prepare technical protocols and reports.
• Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches.
• Knowledge of International Council for Harmonisation (ICH) guidelines related to Product development or Process Development.
• Experience in Formulation Development understanding of execution methodology (based on Critical Material Attributes, Critical Quality Attributes of products.
• Experience in Analytical Research and knowledge on interpretation of the data.

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.
• Committed to Learning & Coaching the team.