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Scientist - Analytical R&D.

10+ years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: M.Pharm./M.Sc./Ph.D. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Scientist - Analytical R&D

Job ID: REQ-10034766
Location: Hyderabad, Telangana, India
Posted on: January 6, 2025
Employment Type: Full-time, Regular


Role Summary:

The Scientist - Analytical R&D is part of the Technical Research and Development (TRD) team within the Global Drug Development (GDD) organization. This role bridges analytical science to clinical performance, driving the transformation of molecules into medicines that improve and extend patients' lives. The position is based in Genome Valley, Hyderabad.


Key Responsibilities:

  1. Analytical and Technical Support:

    • Provide support to the PHAD/project team during various stages of product development (e.g., CSF, FMI, LCM).
    • Design and author analytical documents, such as Analytical Methods, Stability Protocols/Reports, Excipient Compatibility (EC) Protocols/Reports, and APS Protocols/Reports.
  2. Project Management:

    • Assist the Analytical Project Leader in developing and executing the analytical development strategy.
    • Responsible for project-related sample handling, including sampling plans, issuance, storage, and distribution.
  3. Data Interpretation & Communication:

    • Support data interpretation, compiling results, and sharing critical observations with the project team.
    • Ensure timely communication of key issues to relevant stakeholders and management levels.
  4. Collaboration with Stakeholders:

    • Act as a single point of contact for the PHAD/project team and other stakeholders, such as BioPharm, Material Science, and CPP.
    • Manage logistics at third-party testing laboratories and support internal and external audits.
  5. Compliance & SOPs:

    • Ensure adherence to SOPs, GMP, GLP, HSE, ISEC, and Novartis Guidelines.
    • Review test methods and compatibility study plans, ensuring no critical audit findings.
  6. Team Contribution:

    • Actively contribute to team goals and support the execution of project activities.
    • Demonstrate scientific/technical writing and good presentation skills.

Minimum Requirements:

  1. Experience:

    • M.Pharm./M.Sc.: Up to 10 years of relevant experience in testing of solid oral dosage forms.
    • Ph.D.: Minimum of 4 years of relevant experience.
  2. Skills:

    • Proficient in dissolution method development, titration, stability studies, LC method development, DVS, forced degradation, and excipient compatibility.
    • Strong scientific/technical writing and presentation skills.
    • Good communication and collaboration skills.

Why Novartis?

At Novartis, we are passionate about transforming the lives of patients through innovative science and collaboration. Join a community of motivated professionals working towards breakthroughs that change lives.

Benefits and Rewards:
Explore Novartis’ Life Handbook to learn more about the benefits offered to help you thrive personally and professionally.

Diversity and Inclusion:
Novartis is committed to creating an inclusive work environment with teams that reflect the diversity of the patients we serve.

Accessibility:
If you need accommodation due to a medical condition or disability, contact diversityandincl.india@novartis.com for assistance during the recruitment process.


Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Hyderabad, Telangana, India

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