Tech Lead- OSD Formulation

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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. 

Educational qualification: M.Pharm./ 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

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
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/