Extractable & Leachable Scientist
Job posting number: #7150818 (Ref:pf-4885991)
Posted: May 26, 2023
Application Deadline: Open Until Filled
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
* 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
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.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Research and Development#LI-PFE
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.