Role Title:
AT-GTEL, Chennai
Line:
Scientist (Chem Analytical)
Global Job levels
Job Family Group: Research and Development
Job Family: 093- Chemistry-Analytical
Job Category: Research
Job Level: R01 - Associate Scientist
Job Code: 600061
Management Level: J040 (04B)
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.
Accountability:
Responsible for Analytical Method development, Method Validation (for E&L workflow support is preferred), Method transfer, Routine analytical and stability study support for API, Intermediates and different DP formulations with the guidance and mentorship by senior chemist or supervisor.
What You Will Achieve
As a Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. With your deep knowledge in the discipline, you will be an active team member who influences at the project team level. You will perform qualitative and quantitative analyses of organic, inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation or drug product development process.
You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
Responsibilities:
He should adhere both quality and safety compliance according to organizational policies/procedures and regulatory guidelines.
Responsible for development analytical methods and analytical method validation by UPLC, HPLC, GC, for API, DP, Intermediate and Raw materials. Working on E&L workflow is preferred.
Test According to International Standards:
- Extractables & Leachables assessments for finished packaging:
- EMA, US-FDA, USP , , recommendations of PQRI
- Migrations-/simulated use studies
- Leachables shelf-life studies (GMP/cGMP studies)
Should be conversant with the below analytical Techniques
- Headspace coupled to gas chromatography with mass spectral detection (HS-GC/MS)
- Gas chromatography with a mass spectral detection (GC/MS)
- Liquid chromatography with a diode array detection combined with mass spectral detection (HPLC-UV/MS)
- Liquid chromatography with multiple order mass spectral detection (LC/MS/MS)
- Inductively coupled plasma with optical emission detection (ICP-OES) and ICP-MS.
- UV/VIS - Spectrophotometry
- Wet chemical methods: pH, TOC, conductivity, and others
Other experiences:
- Ensure technical output is compliant with all Global Training Curricula for the instrument operations, material handling and certifications related to, Quality Ops, Manufacturing and EHS.
- Ensures compliance to local and corporate procedures and ensures all data packages are audit ready and transferable.
- Coordinate with cross functional teams to ensure timely execution and resolution of all deliverables versus target milestones.
Requirements for all Global Job Levels
Preferred Qualifications
- MSc/M Pharm/ Ph.D
Preferred years of experience
2 to 4 years of Experience
Experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics
Experience working in a regulated environment, such as Good Laboratory Practices {part of GxP}
Effective verbal and written communication skills
Relationships:
- Small Molecule Technology
- Global Technology & Engineering
- Global Supply Chain
- Regulatory Sciences
- Global EHS
- Pharmaceutical Sciences Small Molecule
- Contract Research, Development and Manufacturing Organizations
- Academic Institutes
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
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