Team Leader -FTO-Process-OSD

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 person in Process Development/TT/MSAT to oversee Confirmatory batch/ Trial batch/Scale up batch, Exhibit batch/Pre-validation, Validation batch/ Hold time batches & placebo batches by applying various engineering concepts during optimization and scale up.
Roles & Responsibilities

Responsible for Scale up & Launch activities – Confirmatory, Exhibit, Process Evaluation (pre-validation) & Process Performance Qualification (process validation) studies for New Products for Formulation Manufacturing Unit FTO SEZ PU01 of Dr. Reddy’s.

Planning and execution of Feasibility/Exhibit/Pre-validation/Process Qualification batches for technology transfer of new products.

Participation in risk assessment to identify the Critical Process Parameters and Critical Quality Attributes as part of QbD approach in validation batches for new products. Perform a thorough review of product development report and assess the risk involved during scale up studies and to propose risk mitigation plan for the identified/ anticipated risk.

Process/Product Risk evaluation and recommendation on proposed changes.

Participation in phase gate clearance meeting and technical evaluation meetings for new products.

Ensuring the readiness of all the documents related to process Scale up, Pre-validation, Validation of new products – for preparation, review and approval.

Ensuring quality management system related activities pertaining to products like Incidents, Change notifications, Out of Specification and Out of Trend, Investigation report preparation.

Review of tooling drawing and change parts and approval.

Participation in process safety management activities and ensuring safety measures during execution of confirmatory and monitoring of Feasibility/Exhibit/Pre-validation/Process qualification batches.

Co-ordination with FR&D, Process Development, MSAT, ASAT, AR&D, Quality Control, Quality Assurance, Production & Planning, Regulatory Affairs teams, FTL, Supply Chain management and other CFT’s to meet timeline as per requirements.

Adherence to cGMP, safety procedures & policies at manufacturing sites.

Intimation to shop floor for destruction of Confirmatory/Trial/Pre-validation batches after completion of studies.

Ensuring the Hold time and stability data generation for all the new products.

Arrangement for phase gate discussion with CFTs before pre-validation, post-pre validation & post validation stages to finalize recommendations on observations & results.

Ensuring sharing of knowledge and explaining department practices to the new employees in the department.

Review of Technical evaluation report.

Involvement in the preparation, review, approval and procurement of tool drawing & change parts.

Ensuring the compliance to cleaning validation activities for all the new products.

Preparation and review of SHE report of new products and participation in process safety management activities and ensuring safety measures during execution of confirmatory/exhibit/pre-validation/process performance qualification (validation) batches.

Co-ordinate for the Lean daily management activities.

Extending support to other units of FTO’s in Product Executions, Improvement Projects and their related trouble shooting. 

Participation in organizational events, Personality development programs, Process safety management and other initiations.

Educational qualification- Master in Pharm/ Ph.D in Pharma

Minimum work experience- 10-15 years of Experience in Drug product tech transfers & operations support .

Skills & attributes – 
Technical Skills-
• Exposure to various Oral solid dosage forms like, Tablets (IR, ER, DR etc), Capsules, Pellets, MUPS etc  
• Knowledge of the technology transfers from site to site and R&D to operations.
• Understand the techniques and processes used in Analytical research & Development (AR&D) 

• Knowledge of statestical tools for investigation and data interpretation.

Behavioural Skills- 
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

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/#!/