Research and Product Development Lead

Job Title: Research and Product Development Excellence

The ideal candidate will drive research and product development excellence to ensure a continuous high-quality supply of new or biosimilar drug products and drug substances through the integration of research, manufacturing, and laboratory analytical method development.

This role requires establishing a profound understanding of the science behind products and processes, developing robust analytical methodologies, and achieving industry-first-time quality (right first time) along with manufacturing and laboratory efficiency.

Key Responsibilities:

1. Support the implementation of new initiatives from the business development group to develop new products for local and export opportunities.
2. Research and develop qualitative and quantitative formulae (QQF) for products in question.
3. Prepare laboratory-scale batches for technical evaluation and accelerated stability studies.
4. Submit samples to the business development group for evaluation and acceptability.
5. Arrange raw and packaging materials for pilot-scale batches.
6. Identify and prepare feasibility for manufacturing facilities and equipment required for new products.
7. Prepare three pilot-scale batches and place them on stability studies as per zone requirements.
8. Support procurement for new source development for new products.
9. Lead/direct manufacturing technology transfers and other supportive activities between development centers, sites, external suppliers, etc.
10. Support cGMP product inspections by regulatory authorities and corporate.
11. Support registration of new products with the Ministry of Health and other export regulatory submissions.

Analytical Technology:

1. Support specification setting for new products.
2. Improve product, process, and analytical methods' robustness and achieve excellence in operations.
3. Develop analytical methods for raw materials used in new products.
4. Conduct validation of new developed analytical methods for raw materials.
5. Verify available compendia analytical methods for raw materials.
6. Research and develop stability-indicating analytical methods for new products.
7. Conduct validation of newly developed analytical methods for new products.
8. Verify available compendia analytical methods for new products.
9. Arrange reference standards and impurities for the development of new stability-indicating analytical methods.
10. Implement Process Analytical Technologies (PAT) to achieve real-time release.
11. Validate the first three commercial-scale batches.
12. Conduct real-time stability studies on the first three commercial-scale batches.
13. Support development of artwork for packaging components.
14. Lead/direct analytical method validations, transfers, and other supportive activities between development centers, sites, external suppliers, etc.
15. Investigate product counterfeiting/customer complaints/contamination events and support issue resolution with communication, escalation, and closure.
16. Support bioequivalence/bioavailability studies of new products.

Requirements:

1. Effective communication skills.
2. Team player and motivator.
3. Mature and realistic approach towards job-related assignments.
4. Decision-maker.
5. Diligent.
6. Active.
7. Foresightedness.
8. Strong relationship with policy makers, government, and industry bodies.
9. Good written and oral communication skills in English and Urdu.
10. Strong interpersonal and communication skills.
11. Strong analytical skills with high commitment to excellence.
12. Willing to work under pressure and thrive in a new environment and culture.