Scientist - Car-t (Manufacturing)

7 days ago

Bengaluru, India Aurigene Full time

Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best
- in-class therapies to treat cancer and inflammatory diseases, and a wholly owned subsidiary of Dr. Reddy’s
Laboratories Ltd. Aurigene is focused on precision - oncology, oral immune checkpoint inhibitors, and the Th-17
pathway. Aurigene currently has several programs from its pipeline in clinical development and multiple compounds
at different stages of pre-clinical development. Aurigene has partnered with many large and mid-pharma companies
in the United States and Europe and has 15 programs currently in clinical development. Aurigene is a profitable
company that has continuously invested in its people resources, infrastructure and expertise over the years._ _

**Position **Scientist - CAR-T (Manufacturing)

**Location **Bangalore

**Desired Profile**

M.Sc. (specialization in any Life sciences) with 8-13 years’ or Ph.D. with 0 - 7 years’
experience in Cell Biology, Molecular Biology and Immunology assays

Hands-on experience in developing, manufacturing, and characterizing CAR cell
therapy products is preferred.

In depth understanding of Cell Therapy Research and associated regulatory
guidelines

**Job Description, Key Skills and**
**Competencies:
- Responsible for optimization of CAR cells manufacturing processes using

normal human or patient derived primary blood components, following
ethical practices and QMS as per GMP guidelines
- Actively engage in the manufacture of CAR-T cell therapy products by

diligently prioritizing the lab functions to meet critical deadlines.
- Establish and carefully execute transduction by viral vector and non-viral

vector-based approaches, activation, and expansion of immune cells (T
cells, NK cells, etc) isolated from clinical specimens without
compromising sterility and quality parameters as per the guidelines and
defined criteria by maintaining highest standards.
- Able to communicate effectively in a highly matrixed team environment

to advance the company’s cell therapy pipeline
- Participate and assist in technical transfer and core R&D activities
- To review and document SOPs, protocols and reports pertaining to the

program requirements.
- Work closely with cross-functional teams to design and implement cell

therapy processes and workflow for cell therapy platforms
- Provide critical technical/scientific recommendations for the

manufacturing process improvements
- Work with vendors to evaluate raw materials and consumables for

compatibility with the Manufacturing process
- Coordinate very closely with quality control, quality assurance, supply

chain teams, etc and strictly adhere to the project timelines by preserving
integrity, accuracy, safety, and quality
- Prepare for and participate in compliance monitoring inspections /

regulatory agency interactions.
- Able to troubleshoot experiments, record, analyse, interpret and present

the data in scientific meetings.
- Understanding of systems and process pertaining to sterile practices,

work ethics, safety, health, and environment.

**Competencies**:

- CAR-T manufacture under GMP settings
- Culture of T cells/NK cells and handling of viral vectors
- Statistical analysis, Presentation & Communication Skills
- Documentation and Report Writing
- Interpersonal Skills
- Team Player / Team Management

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