Tech Lead Injectable

Job Summary
We are seeking a dynamic and experienced Lead in Process Development provide technical leadership in ideating strategizing and developing novel formulations to build differentiated product portfolio for serving unmet needs of patients. Ensuring successful establishment of proof of concept through Bioequivalence / Bioavailability studies (BA/BE) or Clinical route scale-up and exhibit batches preparation of filing documents and strengthening technical capability and internal systems related to the function.

Roles & Responsibilities

• 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. 

Qualifications :

Educational qualification- Masters/Ph.D in pharma

Minimum work experience- 7-10 years of experience in Formulation development 

Skills & attributes  
Technical Skills-

• 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 Skills- 

• 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. 

Additional Information :

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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at

Remote Work :

No

Employment Type :

Full-time