15h Left: Senior Associate Scientist-chem Analytical

Role Title AT-GTEL ChennaiLine Scientist Chem Analytical Global Job levelsJob 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 YouPfizers purpose is to deliver breakthroughs that change patients lives Research and Development is at the heart of fulfilling Pfizers 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 AchieveAs a Scientist you will be at the center of our operations and youll 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 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 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 LevelsPreferred Qualifications MSc MPharm Ph D Preferred years of experience5 to 7 years of ExperienceExperience 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 biotherapeuticsExperience working in a regulated environment such as Good Laboratory Practices part of GxP Effective verbal and written communication skillsRelationships 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 LI-PFE