Executive or Senior Executive - Formulation R & D

Key Responsibilities

Formulation Development:

• Lead the development of robust and scalable formulations for solid, liquid, and semi-solid dosage forms, ensuring compliance with regulatory standards.
• Perform pre-formulation and formulation trials to optimize product stability, BE, and manufacturability.

Project Management:

• Manage multiple formulation development projects, from concept to commercialization, ensuring timely delivery.
• Collaborate with cross-functional teams, including analytical, quality, and manufacturing, to meet project goals.

Process Development and Scale-up:

• Develop and optimize manufacturing processes for formulations, including technology transfer to production.
• Address scale-up challenges and ensure the smooth transition of formulations from lab to pilot plant and commercial scale.

Regulatory Compliance:

• Prepare and review technical documents like product development reports, batch manufacturing records, and regulatory submissions (EU / ROW markets).
• Ensure formulations meet domestic and international regulatory guidelines (EMA, ICH etc.).

Problem-solving:

• Troubleshoot formulation and manufacturing challenges related to stability, dissolution, or other quality attributes.
• Investigate and resolve product complaints and deviations.

Innovation and Research:

• Identify and incorporate new excipients, technologies, or methodologies to improve formulations.
• Keep abreast of industry trends, scientific advancements, and regulatory updates.

Team Leadership and Training:

• Mentor and guide junior R&D team members.
• Conduct training sessions on formulation techniques, equipment usage, and best practices.

Skills and Competencies

Technical Expertise:

• Strong knowledge of formulation design, process optimization, and characterization techniques.
• Hands-on experience with formulation equipment (e.g., blenders, granulators, tablet presses, encapsulators).

Regulatory Knowledge:

• Comprehensive understanding of regulatory requirements for formulations in global markets.

Analytical Thinking:

• Strong problem-solving skills with the ability to analyze complex data and derive practical solutions.

Project Management:

• Ability to prioritize tasks, manage timelines, and handle multiple projects efficiently.

Communication Skills:

• Strong verbal and written communication skills for preparing technical reports and interacting with stakeholders.

Preferred Experience

• Experience in developing generic formulations (solid oral, liquid oral, or topical).
• Exposure to regulatory audits and interactions with regulatory agencies.
• Hands-on experience in handling challenges related to solubility, stability, or bioequivalence.