Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

Role title: Extractable & Leachable Scientist

Role Description: Design and execution of E&L studies, Impurity identification and Q3D studies

Responsibilities:

* Responsible for 
1) Method development, feasibility studies
2) Validation/Scientific protocol preparation and execution
3) Development/Scientific/Validation report preparation
4) Maintaining the laboratory chemical and standards
5) Maintaing the lab as per 5S requirements
6) Working with instrumentation team & Validation team for instruments calibration and qualification.                                                                                                             7) Co-ordinating with third party labs for projects handling at external lab                                                           

8) Involving in technical assessments for new equipment's
9) Initiation and closure of gQTS records as per the timelines
10) Maintaining the P2L trainings NLT 95%
11) Sound scientific in E&L area as per the regulatory requirement
12) Ensuring the data inegrity all the time
13) SOP preparation

Qualification:

1) M.Sc./Ph.D. in Chemistry, M. Pharma having more than 5 years of experience.

Skill set Required to perform the role:

1) Must have the scientific knowledge in the area of extractables and Leachable
2) Need to be updated on regulatory guidelines
3) Technically sound and good hands-on experience in various mass spectrometric techniques like LCMS, GCMS, ICPMS, TOC
4) Should have experience on Imprity Identification using Mass spectrometry
5) Must possess good Analytical troubleshooting skills and logical thinking skills and Mass data interpretation
6) Should have knowledge and better understanding on GMP and Data integrity.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.