Process Development/Technology Transfer Team Member

Team Member MSAT

Company Description

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 Description

Job Summary
We are seeking a dynamic and experienced person in Process Development/TT/MSAT to execute and monitor 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

• You will be responsible to demonstrate successful process scale up to ensure smooth execution of confirmatory & exhibit Batches on time.
• You will be responsible to demonstrate successful process scale up to ensure smooth execution of Pre-validation & validation Batches on time.
• You will be responsible to prepare documents required for confirmatory batches/exhibit batches/ Pre-validation & validation Batches at plant. Perform Scale Up correlations for all unit operations from lab scale to plant scale. And provide control strategy for Pre-validation & validation Batches on Exhibit Batches based results.
• You will be responsible to prepare and review of the following document's like, MFR, PIS, Sampling plan, Master production record for Confirmatory batch/ Trial batch/Scale up batch, Exhibit batch/Pre-validation and Validation batch placebo batch but not limited to that.
• You will be responsible to analyse data and provide support in answering process related deficiencies ensuring on time response to regulatory agencies.
• You will be responsible to Prepare and review of the following protocols and reports like Hold time study protocol & report, Submission batch protocol & report, PPQ protocol & report, PORM, eMBRs, MI & BOM.
• You will be responsible to prepare and review of stability study protocol's and reports based on the requirements.
• You will be responsible to prepare and review of tooling specification, Quality risk assessment & miscellaneous trial protocol, and reports
• Support in cleaning verification and validation activity.
• You will be responsible to coordinate with CFTs for timely completion of activities.
• You will be responsible to prepare of detailed investigation reports with appropriate recommendations and CAPA for Submission & validation batches
• You will be responsible to plan and carry out trials based on requirement to identify probably root causes.
• You will be responsible to Initiate change control for where ever required for execution of batches.

Qualifications

Educational qualification: Masters in pharmacy

Minimum work experience: 7-10 years of experience in Process/TT/MSAT

Skills & attributes:

Technical Skills

• Experience in the development/ scale up/ technology transfer of products in Solid dosage forms or technologies.
• Understanding of pharmaceutical process selection
• Ability to prepare technical protocols and reports.
• Experience in process Engineering and risk assessment approaches.
• Knowledge of ICH and other relevant guidelines.
• Familiarity and proficiency in using statistical software.
• Experience in Analytical Research and knowledge on interpretation of the data.

Behavioural Skills

• Excellent communication and interpersonal skills.
• 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 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

Experience LevelSenior Level

---