Novartis Pharmacy & Chemistry Job – Bioanalyst Post Vacancy
Pharmacy and chemistry job opening 2022, Chemistry job opening 2022, Candidates with bachelor’s degree in pharmacy and chemistry may apply for the job vacancy at Novartis. Novartis bioanalyst. Novartis chemistry and pharma job opening 2022. Intrested and eligible candidates may check out all the details on the same below:
Job Id: 344045BR
Job Title: Bioanalyst
Eligibility Criteria:
• University degree (BSc) in pharmacy, chemistry or other equivalent natural science degrees
• Minimum 3 years of working experience in bio-analytical research
• Knowledge of GCP
• Knowledge of regulatory requirements related to assigned area
• Computer literacy.
• Strong communication
• Organizational skills
Your responsibilities include, but are not limited to:
• Provide bioanalytical expertise to the clinical development team across the clinical development network in Sandoz small molecule. Contribute to the activities of the bioanalytical expert network in Sandoz small molecule (process harmonization, knowledge sharing etc.)
• Check the availability of analytical method in CROs, and contribute knowledge to analytical method development and validation as needed. Ensure appropriate CRO selection for the conduct of the bioanalytical part of BE studies in close alignment with Study Manager
• Closely collaborate with the
study responsible Clinical Scientist to enable efficient and on-time study conduct. Work closely with the study team to ensure that all the logistics around bioanalytics is set up, Check the availability of analytical method in CROs, and contribute knowledge to analytical method development if needed.• Review bioanalytical validation reports and ensure that the assay is set up in compliance with regulatory requirements for the region(s) of planned submission. Review study protocol with a focus on bioanalytics (analytical range, anticoagulant, logistics for bioanalytical samples etc.)
• Review bioanalytical protocol and ensure that all necessary requirements are covered. Off-site analytical monitoring (review of chromatograms, results, repeats etc.). On-site analytical monitoring. Review the analytical part of BE study report and ensure that analyses are conducted in accordance with regulatory requirements (i.e handling of outliers, high intra-subject variability etc.)
• Contribute to the preparation of relevant parts of registration documents. Contribute to the development of procedures (SOPs) for bioanalytics and interactions with health authorities in the context of clinical bio-analytics (e.g. scientific advices, deficiencies letters). Contribute to the development of procedures (SOPs) for clinical bio-analytics.
• Ensure conduct of bioanalytical work in compliance with regulatory requirements and internal processes
• Contribute as requested to budget and resource planning for bioanalytical work. Proactive knowledge sharing within the department, SDC, and Sandoz. Contribute as agreed with line manager to other clinical-related tasks. Responsibility for personal and professional development. Providing conditions for and control of the implementation of HSE tasks and requirements in the unit. Other tasks determined during the annual objectives setting process and by KPIs
Apply Online
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