DP MSAT Associate

1. Responsible for Product transfer / new product introduction Technology Absorption Process qualification activities for Biological products/ Injectable products
2. Monitoring support and execution of trial scale up manufacturing of clinical batches & Process validation batches and site to site transfer of biological products and new products from R&D to manufacturing plant.
3. Knowledge in Aseptic manufacturing operations of fill finish facility (liquid & lyo injectables)
4. Initiation Review and Approval of change controls Incidents and risk assessment with respect to transfer of biological products and new products from R&D to manufacturing plant.
5. Able to design execute and conclude on the mixing / homogeneity studies.
6. Preparation and approval of material reservation in System Application and products (i.e. SAP).
7. Process / Product Risk assessment and evaluation recommendation on proposed changes.
8. Responsible for Execution and participation of Pre-validation / Process performance qualification batches and Continued process verification Process simplification machine change batch size change and other routine Validation / Qualifications.
9. Responsible to perform/review the investigations arising from incidents out of specifications out of trends product failures to identify the root cause and implement appropriate corrective and preventive actions.
10. Co-ordination with Production Quality Assurance Regulatory Affair Quality Control Supply Chain Management & vendors for collection of data /reports.
11. Preparation Review and approval of following documents but not limited too
    • Trial batches/ Phase-I/Phase III/ Pre-validation/ Process performance qualification batches Protocols & Reports.
    • Master Formula Record Batch Manufacturing records BOM for Raw Material Packing Material
    • Equivalency Report Technical and scale up evaluation Reports Hold time Study Protocol and Reports.
    • Filter validation studies
12. Exposure to global regulatory filings (Ex: USFDA and EU) and has been part of CMC review is an advantage.

Qualifications :

Educational qualification:  B. Pharm Masters (. or in life sciences or pharmaceutical sciences or ) or a Ph.D.

Minimum work experience:

Minimum 10-15 yrs. of experience in the product manufacturing development and tech transfer activities for biological molecules/ injectable products knowledge of Aseptic manufacturing & filling operations.

Skills & attributes:
Technical Skills
Thorough knowledge of Biologic formulation and filling processes.
Knowledge in Aseptic manufacturing operations of fill finish facility (liquid & lyo injectables)

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 formulation filling and assembly processes in a manufacturing environment. 

Behavioural skills
Ability to convey complex injectable 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.

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 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