Tech Lead- OSD Formulation

Job Summary
We are seeking a dynamic and experienced Business Leader in Product ideation team for New Product ideation successful product introduction & development by Collaborating across Portfolio Marketing Medical affairs & Research & development team to create an innovative advantage for the organization. Also to build scientific capability as a part of product delivery and organization by creating an innovative pipeline of Technology based on High Value products to meet the growth objectives of India & other emerging markets.

Roles & Responsibilities

• You will be responsible for the product evaluation based on complexity innovation potential development challenges and alignment with company goals. You will ensure a robust and thorough product selection process minimizing post-introduction failures and facilitating a healthy inflow of products into the in-house development pipeline.
• You will be responsible to conduct an extensive literature search to gather relevant scientific data and summarize pertinent information on product complexity and innovation strategies from various scientific journals industry publications and academic research.
• You will be responsible for the assessment of anticipated challenges in product development considering technical regulatory and market-related aspects and propose effective strategies to overcome them.
• You will provide technical insights and guidance to ensure a smooth transition from product selection to the development phase and facilitate effective communication and collaboration between the development team and the product selection team.
• You will be responsible to conduct detailed risk assessments for each product and collaborate with cross-functional teams (CFTs) to discuss and mitigate potential risks identified during the selection process.
• You will be responsible to engage with the Global Generic Business Development (GGBD) team to assess dossier quality and conduct gap analyses for potential products.
• You will be responsible to lead the product ideation workshop and drive the development of a differentiated innovative and high-value product portfolio in the Brazil and India (BRaIN) vertical thereby ensuring long-term success and competitiveness in the market.
• You will be responsible to implement sensory and product experience testing to evaluate the appeal and quality of potential new products.
• You will be responsible for implementing strategies to drive innovation in dosage form design and facilitate the successful development of complex and differentiated products.
• You will be responsible to provide technical leadership to the team to understand and define the scope of overall project development and finalise the development strategy with anticipated risk and mitigation plan in form of risk registry.
• You will be responsible for effective logistical readiness to facilitate a smooth transition for the development team and contribute to the successful introduction of products by establishing an efficient inventory management system to monitor and manage the availability of essential components 
• You will be responsible to facilitate the application process for import licenses related to reference products for testing and analysis purposes.
• You will be responsible to understand recent trends in new product ideation methodologies Technology based Innovations unmet medical needs in Therapy areas for product selection product development and professional standards anticipate scientific needs and champion the change management in line with identified requirements by Leadership/Management council to meet business needs.
• You will be responsible to lead & develop a self-motivated dynamic scientifically sound team of pre-formulation & reverse engineering scientists who can execute & demonstrate better understanding and facilitate product development using pre-formulation & reverse engineering concepts with unorthodox & out of the box methodologies.
• You will be responsible to lead goal setting and building capabilities for the team. Guide scientist to work on safety rules & good laboratory practices across functional & project teams to ensure deliverables. Also motivate them to come up with Product Based ideas for unmet medical need in India & Emerging markets in Selected Therapeutic Areas while keeping organizational sustainability initiatives. 

Qualifications :

Educational qualification: ./ Ph.D 

Minimum work experience: 12-15 years of experience in Formulation Development
 

RESPONSIBILITIES

Full kitting support PDC and timelines finalization
Batch size calculation
Designing Prelimnary strategies

formulation Development: Participate in strategizing the sourcing of API and raw materials

Monitor the development for robust effective and bioequivalent drug product in timely manner adhering to safety and quality standards.         

 Participate in discussion with CFT to develop an effective strategy of drug product development IP Bio etc.

Participate in discussions with experts and team members and guide the team in different stages of development (pre-formulation studies material characterization drug-excipient compatibility etc.) RLD characterization including reverse engineering formulation designing and optimization processes designing and scale up).

Participate in developing effective risk evaluation and risk mitigation plan for drug product at every stage of development

Review data generated and participate in discussions with experts to conclude on prototype(s)

Identify and promote use of digital tools into drug product development

Regulatory Support

Integrate all inputs from functional experts to develop regulatory strategy
Participate and guide the team to develop effective documentation            
Review regulatory documents for submission to RA

Innovation and Intellectual Capital Development

Provide support internally as formulation subject matter expert
Identify opportunities to strengthen IP of the company

People Management & Coaching & Mentoring

Provide guidance including technical to other team members for timely completion of project                                                                             
Identify and promote personal learning and development of team members

Technical enhancement

Identify areas of technical improvement in product development and implementing digital tools.
System improvement by identifying and implementing improvement in SOP and internal guidance 

Finance

Provide budgeting inputs for the team projects
Monitor cost of project and handle deviations
Providing Inputs for Cost improvement

Departmental Support SOP and Safety Guidelines

Prepare and/or review SOP pertaining to the function
Facilitate lab and equipment maintenance and implementation of company safety standards
Contribute to Safety guidelines and Practices updation

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