Quality Control Associate Bioassay

• You will be responsible for Bio-complexity assessment and provide inputs for product selection for United States Europe and Emerging markets.
• You will be responsible for providing Biopharmaceutical based strategic support for assessing the feasibility and complexities of new product development conducting comprehensive gap analyses and ensuring alignment with regulatory requirements for successful market entry.
• You will be responsible for identification of bio relevant/bio discriminatory media/appropriate in-vitro tools based on Critical Material Attributes & Critical Quality Attributes for periodical Management reviews.
• You will be responsible to support in designing & guiding the team in modeling and simulation of available data using data Analytical Tools and Software.
• You will be responsible for risk assessment for granting approval for pilot bio studies and early bio-manufacturing through Best Available Technologies (BAT) meetings and phase gates.
• You will be responsible for managing the team and provide them the guidance and support in setting up their goals.
• You will be addressing regulatory queries Deficiency responses and guiding the Product Development Team.

Qualifications :

Educational Qualification

An . . Microbiology Biochemistry or Biotechnology

Minimum Work Experience

8-10 years

Skills & Attributes Technical Skills:

• Strong understanding of the Biologics/Biosimilar industry including processes regulations and trends.
• Hands-on experience in cell-based bioassays SPR technique FACS techniques. 
• Strong knowledge and hands-on exposure to cell culture techniques specifically for working in Bioassay (BA) Labs.
• Hands-on experience in Biochemical analysis techniques specifically Electrophoresis Enzyme-Linked Immunosorbent Assay (ELISA) and Polymerase Chain Reaction (PCR) with a focus on Analytics.
• Working experience in a cGMP (Current Good Manufacturing Practice) environment with a special emphasis on Good Documentation Practices (GDP).
• Strong knowledge in protein chemistry including an understanding of protein structure function and relevant analytical techniques.
• Strong understanding about bioassay technology transfer method validations & QMS 

Behavioural Skills:

• Prioritizes effective communication and demonstrates a performance-oriented mind-set.
• Effective verbal and written communication skills.
• Performance-oriented approach consistently striving for high standards.
• Demonstrates flexibility in working shifts and a clear understanding of team dynamics.

Additional Information :

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