Formulation Scientist

We are seeking a dynamic and experienced Specialist in Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of robust stable formula and process for given product from bench scale to commercial level.

Roles & Responsibilities

• You will be responsible to Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization.
• You will be responsible to evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase.
• You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product.
• You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc.
• You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development.
• You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function.
• You will be responsible to provide guidance to develop formulation capabilities within team.

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Experience in end-to-end product development and troubleshooting.
• Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets.
• Good theoretical and practical understanding of different stages of formulation research and development
• Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools.
• Basic understanding of engineering principles & process controls related to equipment and process scale ups.
• Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs).
• Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects.

BehavioralSkills

• Excellent communication and interpersonal skills.
• Business Acumen & Decision Making
• 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.