Scientist - Quality Control

2 weeks 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 - Quality Control

**Location **Bangalore

**Desired Profile**
M.Sc chemistry (Analytical/Organic/General) or M.Pharm (Pharmaceutical Analysis /
Pharmaceutics with 8 - 13 years’ experience or Ph.D. with 0 - 7 years’ experience.

**Job Description,**
**Key Skills and**
**Competencies:
- Execution of method development, method validations, technology transfer to CMOs

using different instrumental techniques for both DS and DP as per the requirement of
- Practical analytical experience working with dosage forms including solids and liquids

for oral and parenteral administration.
- Close co-ordination with process and formulation development teams and assist PD

team in screening formulations trails. Fair understanding of the pharmaceutical

development process.
- Basic knowledge of Analytical Quality by Design (AQbD) principles and optimization

techniques.
- Hands on experience of instruments like HPLC/GC-HS/FTIR/Dissolution/Polari meter/

KF Auto titrator/ DSC/PXRD/PSD/LC-MS.
- Plan stability charging of both DS and DP, ensure on time pulling of stability samples

and ensure timely execution of stability analysis and signoff of stability compilation

reports.
- Stability study protocols, reports preparation and handling of incidents / deviations /

OOS/OOT.
- Preparation of Specifications, STPs and Method verification reports for developmental

studies.
- Through involvement in investigation related matters using different instrumental

techniques.
- Monitoring and ensuring the timely completion of assigned analytical works to

CDMO’s and CMO’s.
- Good documentation skills for recording research and ability to summarize results and

data in concise presentations, development reports, summaries etc; experience in

writing and supporting regulatory documents (E.g., CMC technical sections)
- Qualification & Maintenance of reference standards, Impurity standards, timely

retesting and ensure the availability all the time.
- Knowledge on Instruments qualifications (IQ/OQ/PQ) and SOPs preparation

(Instrumental and general SOPs)
- Indent of chemicals and reagents.
- Follow and ensure laboratory SOPs and ensure GMP and GLP compliance in QC lab.
- Understanding of systems and process pertaining to safety, health and environment.

Competencies:

- Presentation & Communication Skills
- Excel Skills
- Scientific Report Writing
- Interpersonal Skills
- Team Player / Team Management

**Company**
**Overview

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