Bioanalyst

Novartis India  Hyderabad, Telangana, India

Job Description

Sandoz aspires to become the leading and most valued generics company.

At Sandoz, we are planning capital expenditures of several hundred million USD over the next 5 years to expand production capacity in key markets for small molecules and biopharma

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, contribute knowledge to analytical method development and validation as needed. Ensure appropriate CRO selection for conduct of the bioanalytical part of BE studies in close alignment with Study Manager
  • Closely collaborate with the study responsible Clinical Scientist to enable an efficient and on time study conduct. Work close with the study team to ensure that all the logistics around bioanalytics is set up, Check the availability of analytical method in CROs, 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 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 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 preparation of relevant parts of registration documents. Contribute to development of procedures (SOPs) for bioanalytics and interactions with health authorities in context of clinical bio-analytics (e.g. scientific advices, deficiencies letters). Contribute to 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 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

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

  • University degree (BSc) in pharmacy, chemistry or other equivalent natural science degree
  • Minimum 3 year of working experience in bio-analytical research
  • Knowledge of GCP
  • Knowledge of regulatory requirements related to assigned area
  • Computer literacy.
  • Strong communication
  • Organizational skills

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

SANDOZ

Business Unit

Product Dev SZ

Country

India

Work Location

Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

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