MSAT Associate

Role Summary:

Responsible to provide technical support for the purification processes for different commercial & developmental products such as technology transfer related activities creating primary document package and CMC deliverables for regulatory filing. Accountable for process validation and life cycle management for different commercial products including business continuity requirements/initiatives for downstream.

Primary Responsibilities:

1. Scientific evaluation of process for feasibility scale up scale down and direct the technology transfer of downstream process aiming for right first time scale up at manufacturing scale.

2. Involvement in conducting required studies in process performance qualification (PPQ) batches for drug substance stages and closure of associated documents across the plants.

3. Preparation and technical review of process/product related investigations and proposal of appropriate corrective & preventive actions along with their implantation within stipulated timeline.

4. Preparation and technical review of QMS documentation like investigation reports change controls and technical write ups (Protocols reports risk assessments etc.) for appropriateness of documents.

5. Involve in process improvements through scientific assessment & implementation of continuous improvement projects.

6. Responsible for compliance to quality of process.

7. Responsible for review of process trends and Continued Process Verification for products produced in both microbial and mammalian cell culture manufacturing facilities.

8. Responsible for audit and regulatory queries management.

9. Review and coordination with CFTs for CMC aspects of the projects for different regulatory authorities.

Secondary Responsibilities:

1. To assess the feasibility and implementation of advanced technologies.

2. Responsible to review assessment of new/alternate vendors and materials.

Qualifications :

Educational Qualification

A . and a Masters (. or .)

Minimum Work Experience

5-8 years (with Masters) of experience in a Biopharmaceutical industry

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.

Additional Information :

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-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. 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 900000 patients having benefited from our products till date.

Benefits Offered

At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time