Senior Associate Scientist-Chem Analytical

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: R02 - Senior Associate Scientist
Job Code: 602689
Management Level: J050 (05A)

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 E&L workflow support for variety of pharmaceutical matrices, ranging from aqueous buffered saline solutions, more complex pharmaceutical formulations (e. g. , containing Polysorbate, PEG, protein solutions) and even very complex matrices (e. g. , oily solutions, syrups, ointments). , for the activities such as Analytical Method development and Method Validation.

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:

Should have extractables and leachables testing experience for pharmaceutical and biopharmaceutical products as:

• Primary packaging for pharmaceuticals (inhalation, parenteral, ophthalmic, topical and oral drug forms), e. g. bottles, tubes and bags.
• Secondary packaging, e. g. labels, packaging made from cardboards, plastic, metals and laminates.
• Delivery systems, e. g. syringes, transdermal patches and dosage systems.
• Leachables Method Development and Validation.

Test According to International Standards:

• Physico-chemical testing according compendium monograph:

Such as: Ph. Eur 3. X and 3. 2, USP , JP 7 and customized methods

• Organic and inorganic residues, ICH Q3A, Q3B, Q3C and Q3D.
• Extractables & Leachables assessments for finished packaging:
• EMA, US-FDA, USP , , recommendations of PQRI
• Sound scientific research leachables-screening studies
• Migrations-/simulated use studies
• Leachables shelf-life studies (GMP/cGMP studies)
• Quantitative and qualitative determinations of plastic additives and related substances (impurities/breakdowns)

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.
• Ion chromatography (IC)
• Infrared spectrophotometry (FTIR)
• UV/VIS - Spectrophotometry
• Total organic carbon analysis (TOC)
• Wet chemical methods: pH, TOC, conductivity, and others
• Structural elucidation by high resolution mass spectrometry, fraction collection by HPLC, NMR analysis (desirable)

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/MPharm/Ph. D.

Preferred years of experience

5 to 7 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
• Launch Excellence
• Pfizer Manufacturing Sites
• External Supply
• Global Supply Chain
• Regulatory Sciences
• Global EHS
• Procurement
• Pharmaceutical Sciences Small Molecule
• Contract Research, Development and Manufacturing Organizations
• Academic Institutes

Research and Development

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