Process R&D Scientist, API Fermentation

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 Scientist in Fermentation for Active Pharmaceutical Ingredient (API) development to develop highly efficient, cost effective, robust and scalable fermentation especially downstream processes for intermediates/APIs.

Roles & Responsibilities

• Process development for the extraction and purification of biomolecules from recombinant or classical fermentation to meet the API specifications.  It may include but not limited to chromatographic methods, membrane-based purification, iso-electric precipitation and crystallisation.
• Design and conduct experiments related to process optimization and/or feasibility studies to develop safe and robust process keeping in view QbD principles and plant execution.
• Maintain GLP (good laboratory practices) & GDP (good documentation practices) in the laboratory in order to adhere to SOPs & compliance. 
• Participate in the smooth running of lab meetings and contributes to troubleshooting for potential causes of experimental failures and process performance aspects as relevant.
• Data collation and presentation in a comprehensive manner for further analysis.
• Generation of technical presentations elaborating each experimental outcome in order to communicate technical information within the function.
• Maintain inventory of experiments and ensure completion and draw proper conclusion of each experiment.
• Draft descriptive scientific reports facing team deliverables (e.g., Process development summary, Tech memo, Process description summary, campaign planning and protocols, etc.) maintaining global quality and as per regulatory standards.
• Collaborate with DQA for review, data authentication and archival of LNBs, campaign plan/ protocols/ reports.
• Oversee lab operations, equipment maintenance, safety and quality.
• Ensure compliance of the team with safety and quality standards and systems for smooth lab functioning.
• Coordinate with 'Lab-Ops' and 'Engineering' teams in case of equipment break-down to minimize the downtime.
• Ensuring the availability of RMs and consumables required for project.
• Facilitate plant execution and solve scale up related issues at plant. 
• Share common work in the laboratory to help smooth execution of projects. 
• Support the internal & external customer (AR & D, TSD, IP, RA, DQA and cross functional team) by providing technical inputs in order to maintain strong relations with customers. 
• You will be responsible to develop a robust process through initiating, designing, developing, executing, and implementing scientific research projects in collaboration with others. This involves designing and conducting experiments, collecting and interpreting data, and interacting with relevant experts to ensure successful scale-up and technology transfer. 
• You will be responsible to investigate the feasibility of applying scientific principles to potential inventions, participate in patent application development, coordinate interdepartmental activities, and contribute to scientific literature and conferences.
• You will be responsible for carrying out validations of the optimized process, actively participating in tech transfer, providing plant support during scale-up, troubleshooting issues, and monitoring plant performance relative to laboratory results for the designated stages. Additionally, you would assist in preparing reports and documentation necessary for gate clearances.
• You will be responsible to conduct stage wise drafting and compilation of regulatory documents and data as per the guidance to assist in Drug Master filling (DMF) and approval for drug substance.
• You will be responsible to develop scientific acumen & innovation culture by reading, discussing scientific literature and be updated with the new developments in one's own area of work- Look for opportunities for application of new learnings in discussion with experts. 

Educational qualification: M.Tech / M.S (Research) in biological sciences /Biotechnology/Biochemical Engineering

Minimum work experience: 2 years of High cell density fermentation downstream process development.

Skills & attributes: 
Technical Skills

• Good understanding of pharma product development, Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Experience in fermentation (upstream/downstream).
• Hands-on laboratory/pilot scale process experimentation in downstream
• Knowledge of microbiology, DNA technologies, metabolic engineering, biochemistry, Design of Experiments (DOE) and screening techniques is an advantage
• Theoretical knowledge of International Council for Harmonisation (ICH) guidelines on process validation

Behavioral Skills 

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Business Acumen & Decision Making.
• Performance oriented and good in developing and leveraging relationship.
• 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/#!/