MSAT Associate - Hyderabad, India - Dr Reddy's Laboratories Limited

Description

Job Summary
We are seeking a skilled professional to serve as a specialist in upstream/downstream operations, specializing in processes like mammalian cell culture, perfusion technology, scale-up, single use technology, Bioreactor characterization, Chromatography, Ultrafiltration, and Virus Filtration. The role involves authoring validation protocols, conducting risk assessments, utilizing tools for process verification, and actively participating in technology transfers to ensure compliant, efficient, and continuously improved manufacturing processes.

Roles & Responsibilities

• You will serve as a Subject Matter Expert (SME) and actively engage in hands-on operations involving processes like cell culture, tech-transfer from lab to manufacturing scale, Chromatography, Ultrafiltration, TFF, Virus Filtration, and handling drug substance.

• Your responsibilities include authoring process validation protocols and reports, conducting risk assessments, utilizing tools like Continued Process Verification (CPV), PAT Tools, and statistical analysis tools (e.g., JMP).

• You will be responsible for generating various documents related to process monitoring, investigating incidents for Deviations, and working with Quality Management Systems (QMS).

• Your role also involves active participation in technology transfers and implementing upstream/downstream processes including facility fit modelling based on process needs.

• You will build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.

• You will be responsible for ensuring compliance, control, cost-effectiveness, and continuous improvement of manufacturing processes.

Educational qualification: A B.Tech. and a Master's (M.Tech. or M.Sc.) or a Ph.D.

Minimum work experience: 5-10 years (with Master's) of experience in a Biopharmaceutical industry

Skills & attributes:
Technical Skills

• Thorough knowledge of Biosimilar, cell-culture, mAb purification processes, and current Good Manufacturing Practices (cGMP).

• Proficiency in scaling up manufacturing processes from laboratory-scale to larger production scales and transferring technology between different manufacturing sites at a clinical or commercial facility.

• Experience and understanding of Continued Process Verification.

• Familiarity and proficiency in using statistical software, particularly JMP, for data analysis, interpretation, and decision-making in the context of process optimization and control.

• Expertise in authoring documents related to cGMP and developmental processes, including process validation protocols and reports.

• Ability to identify, analyse, and resolve issues or challenges that may arise during the manufacturing process, ensuring continuous improvement.

• Skills in conducting risk assessments and comprehensive understanding and application of Quality Management Systems.

• Expertise in designing, optimizing, and implementing upstream and downstream processes in a manufacturing environment.

Behavioural skills

• Ability to convey complex upstream and downstream processes and technical information clearly to diverse audiences, including team members, management, and cross-functional teams.

• Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.

• Strong analytical and problem-solving skills to address challenges.

• Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.

• Takes responsibility and maintains a disciplined and agile approach to execution.

About 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