Tech Lead - Injectable

Job Summary

• You will be responsible to ensure the development of robust, effective, and differentiated drug products that adhere to safety and quality standards. Utilizing pharmacokinetic and clinical understandings, guiding team members, and facilitating effective risk evaluation and mitigation throughout the product development process.
• You will be responsible to Integrate all inputs from functional experts to develop regulatory strategy and pathway. Participate and guide the team to review regulatory documents for submission to Regulatory Affair agencies.
• You will be providing support internally as subject matter expert to identify opportunities for strengthening Intellectual Property (IP) of the organization. Identify areas to develop internal formulation development guidelines to identify and develop capabilities that enable future complex differentiated product development. 
• You will be responsible for providing technical guidance through scientific discussions and knowledge-sharing within the team. Also evaluating individual team members' areas of improvement, and coaching and mentoring them to enhance their capabilities.
• You will be responsible for ensuring implementation of internal systems of project management to facilitate Cross Functional Team (CFT) understanding of the project to assist flawless and timely delivery of project.
• You will be responsible to identify areas of technical improvement in product development including clinical and pharmacokinetic understanding, facility building, implementing Quality by Design (QbD) /Design of Engineering (DoE) principles.
• You will be responsible for budgeting, monitor cost of the project and maintain cost effectiveness. 

Educational qualification

• In-depth knowledge in novel/complex drug delivery systems with sound technical competence over various platform technologies.
• Understanding the regulatory aspects in the domain of generic and new product development.
• Developed at least one complex/differentiated product and have delivered >5 products overall.  
• Experience in New product ideation and Evaluation.
• Experience of product development and Technology transfer for global markets.
• In-depth understanding of pharmacokinetic and pharmacodynamics response relationship between animals and human.
• Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects.

Behavioral

• 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. 

About the Department

Integrated Product Development Organisation

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages

Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered