Quality Control Specialist (CAR-T)

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.

Role Responsibilities:

As a QC/Analytical Scientist/Sr Scientist, a typical day might include the following:

• Collaborate with partner groups in research and development and manufacturing to bring in-house, develop, and validate QC/analytical methods to evaluate novel CGT candidates using QC/analytical methods such as digital PCR, qPCR, ELISA, Flow Cytometry, electrophoresis, Spectrophotometry, cell staining, cell viability, cell morphology, and cell-based methods (e.g., potency, biological titer) for tech transfer to GMP testing groups.
• Proactively engage and lead troubleshooting activities for established methods by providing scientific support across the manufacturing life cycle.
• Independently create scientifically sound project QC/Analytical plans and relevant experiments using high-level project timelines and goals.
• Perform the scientific interpretation and reporting of the results. Present results to management and at cross-group meetings.
• Use statistical tools to develop quantitative measures in decision-making around assay validation and performance.
• Drive the writing, review and approval process of procedures, protocols, reports and GMP documents.
• Stay at the leading edge of industry trends and agency requirements in the CGT analytical space as it pertains to development and transfer in the GMP environment.
• Order reagents and lab materials. 
• Create and maintain high quality records of all experimental work carried out.
• Drive experimental troubleshooting investigation via QMS system/SOPs (e.g. OOS/OOT/Deviations/RCA/CAPA)
• Train junior-level group members and act as a mentor within the laboratory.

Additional information

Experience and skills required

QC/Analytical Scientist: 3-6 years of Cell therapy/Biologics experience.

Senior QC/Analytical Scientist: 6-12 years of Cell therapy/Biologics experience.

• You can comfortably work in a dynamic, fast-paced, closely collaborative environment, on multiple projects in parallel, independently or as a group.
• Experience with a wide range of QC analytical techniques, particularly cell-based analytical methods (Incucyte/xCELLigence), qPCR, ELISA and flow cytometry.
• Excellent demonstrated understanding of quality and regulatory guidance and documentation governing cell-based and biologics development.
• Experience in the Quality Control (DS/DP testing and release) of cell and gene therapy products and analytics in PD or GMP environments.
• Quality-minded, attention to detail, problem solving and proactive attitude.
• Detail-oriented, curious to learn and implement new ideas and techniques and lead multiple projects in a team-based environment.
• Able to work under rapidly shifting priorities and timelines.
• Highly motivated, rigorous, flexible, innovative, and good team-working skills
• Excellent organizational, communication and time management skills
• You're interested in developing into a mentor and leader within the group.

Prior experience in analytical method development, molecular biology, Cell therapy, and Vector analytics is highly preferred. Level is determined based on qualifications relevant to the role.

PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology or a relevant life-science discipline, with relevant industry experience within QC and analytical method development function.