Job Description

Company DescriptionDr. 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 transparencyDr 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 professional to design expression constructs, utilizing expression platforms to deliver cell lines expressing Biotherapeutics. The role involves developing methods for establishing and characterizing biotherapeutic cell lines, evaluating productivity and generational stability, collaborating internally for departmental objectives, and providing stable, high-expressing cell lines/banks through successful process and formulation development.Roles & Responsibilities

• You will be responsible for designing and preparing vector constructs for cell line development, prioritizing activities, analyzing moderately complex data, and identifying/resolving technical or execution issues in experiments.
• Your role includes interacting with other department groups (process development, formulation development, and analytical development) to plan and prioritize activities, as well as driving and guiding the team to execute experiments with expected quality and within defined timelines.
• Additionally, you will explore scientific innovations and evaluate the implementation of new technologies to drive development, shorten timelines, and improve methodologies in cell line development as the industry evolves.
• You will be responsible for developing and designing methods to determine gene copy number and sequencing of the gene of interest in cell lines used in manufacturing and under development. You will analyze data, identify and troubleshoot issues, and prepare knowledge and technology transfer documents for cross-functional transfer of methods to characterize cell lines if needed.
• You will lead the development of the process for establishing master cell banks (MCB) for different product cell lines, including designing experiments, ensuring the distribution of responsibilities among the team, and interacting with various development and manufacturing functions and stakeholders to enable smooth execution of activities.
• You will also prepare document recording sheets for accurate and detailed data recording, facilitating the smooth transfer of knowledge and methods to the manufacturing department.
• You will be responsible for writing and reviewing technical reports related to establishing cell lines, determining their genetic stability, and establishing methods and acceptance criteria for MCBs.
• You will prepare knowledge transfer documents for methods of genetic characterization of cell lines under development, review SOPs for equipment operation and development activities, and enhance documentation systems for improved traceability.
• You will be responsible for serving as the liaison for the cell line development team in project meetings as a Subject Matter Expert (SME) to provide and obtain information, and ensure clarity regarding project/activity status and requirements from different departments.
• Your role includes prioritizing activities to align with and achieve project and business goals, presenting findings and results in project meetings and to senior management, facilitating team in meeting timelines, and interacting with various development groups and stakeholders to enable the implementation of new documentation and quality systems.
• You will be responsible for actively collaborating with internal development groups to obtain licenses and prepare Material Transfer Agreements (MTAs) for the receipt and shipment of materials.
• Your role includes providing technical advice in case of any issues or difficulties faced at CTO/CLO and compiling and reviewing results and reports received from agencies for the timely accomplishment of goals.
• You will be responsible for supporting the implementation of quality processes in the cell line development workflow, including assisting in quality incident investigation to identify root causes and implementing CAPA (corrective and preventive actions) as assigned.
• Additionally, you will provide support for internal quality audits and address CAPA to improve existing procedures and documentation. Your role includes supporting relevant data to the department head or concerned individuals to facilitate any external audits.
• You will also contribute to the implementation of new documentation and quality systems within the function. You will ensure the completion of IOQ (Installation and Operational Qualification) and PQ (Performance Qualification ) for new equipment.
• Your responsibilities involve conducting safety audits in different safety zones of the facility, participating in routine safety-related activities, and enabling the implementation of safety systems within the team. Additionally, you will support safety incident investigations to identify root causes and implement assigned CAPA.

QualificationsEducational qualification: A Master's or Ph.D. in cell biology, biochemistry, or other related scienceMinimum work experience: 5 years of experience with a Master's or 1 year with a Ph.D.Skills & attributes:Technical Skills

• Knowledge of product development in biopharmaceutical industry.
• Basic understanding of existing and emerging technologies in cell line development, cell culture, cell banking and/or related areas and CMC (Chemistry, Manufacturing, and Controls), Quality, and Regulatory requirements.
• Expertise in vector construction, molecular biology, cell line generation and screening techniques/systems and data analysis tools.
• Knowledge and experience in development of biotherapeutics using different expression platforms.
• Understanding of cell banking processes as per GMP (Good Manufacturing Practices) requirement.
• Basic understanding of the CMC requirements in the related area.

Behavioural skills

• Ability to lead and manage a team for delivery under stringent timelines with expected quality.
• Solid writing, communication and presentation skills.
• Excellent problem solving and critical thinking skills.
• Ability to mentor the team to reach their full potential.
• Excellent organization and planning skills.
• Ability to make decisions that require choosing between limited alternatives to resolve complex problems.
• Excellent interpersonal skills with ability to adapt effectively to rapidly changing organization issues, structures and dynamics.

Additional InformationAbout the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales - future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities - in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.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/#!/

Dr. Reddy's Laboratories