Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Scientist - Chem Analytical
Job Description
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.
Candidate Profile
• MSc / Mpharm /Ph.D
• 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
Additional Information
Experience : 9 to 12 years
Qualification : MSc / Mpharm /Ph.D
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th January 2025
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Chennai Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email