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: R03 - Scientist
Job Code: 602741
Management Level: J060 (06C)
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.
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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, Method Validation, Investigation, Tox assessment and Regulatory support.
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 leachable 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.
- Single-use systems or other process materials used during pharmaceutical or biopharmaceutical manufacturing, e.g. filter systems, tubing, connectors, storage bags, seals, and membranes
- Leachable Method Development and Validation
- Leachable Studies on Stability Samples
Test According to International Standards:
- Physico-chemical testing according compendium monograph:
Such as: Ph.Eur 3.X and 3.2, USP < 661.X>, 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 < 1663>, < 1664>, recommendations of PQRI
- Sound scientific research leachables-screening studies
- Migrations-/simulated use studies
- Leachables shelf-life studies (GMP/cGMP studies)
- Extractables and leachables assessments for single-use systems (SUS) that are used in pharmaceutical production:
- EMA, US-FDA, USP < 665>, < 1665>; current recommendations of ASTM, ISPE, BPSA, BPOG, PDA can be taken in account
- 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)
- Programmable temperature vaporizer gas chromatography with mass spectral detection (PTV-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)
Toxicological assessments of extractables/leachables studies for medicinal products:
- Derivation of health-based thresholds, such as Permitted Daily Exposure (PDE) values, as needed for validation of packaging materials
- In silico toxicology for the assessment of substances without sufficient data by using TTC-concept or other QSAR tools
- Assessment of genotoxic/carcinogenic substances according to ICH-M7 or ICH S9.
- Toxicological assessments of extractable/leachable studies of medical devices according to ISO 10993-17.
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.
- Work with the Quality Assurance and other cross functional teams to facilitate the consistent, disciplined execution of the LIR/ER/CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.
- 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
9 to 12 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}
Demonstrated technical expertise in functional verification of design
Working knowledge of applicable industry test standards, relevant regulatory guidance, Design Controls and Product Development Process
Able to interact effectively with peers and leaders as part of a multi-disciplinary team
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
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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