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Scientist - Analytical R&D

4-10 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Scientist - Analytical R&D

Location: Hyderabad, India (Genome Valley)
Job ID: REQ-10034766
Date Posted: Feb 03, 2025
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No


Job Summary:

As part of the Technical Research and Development (TRD) team within Global Drug Development (GDD), the Scientist in Analytical R&D will provide analytical and technical support at various stages of product development. The role bridges analytical science with clinical performance, helping transform molecules into medicines that improve and extend patients' lives.


Key Responsibilities:

  • Analytical Support:

    • Provide analytical and technical support to the PHAD/project team at different stages of product development, including CSF, FMI, and LCM.
    • Design and author analytical documents such as analytical methods, stability protocols/reports, excipient compatibility (EC) protocols/reports, and APS protocols/reports.
  • Project Development Strategy:

    • Support the Analytical Project Leader in setting analytical development strategies.
    • Interpret data, compile results, and share critical observations with proposals to the project team.
  • Sample Handling and Logistics:

    • Manage project-related sample handling, including sampling plans, issuance, storage, distribution, reconciliation, and destruction of samples.
    • Manage logistics for project activities, including external testing laboratories and third-party collaborations.
  • Planning and Communication:

    • Support the planning for assigned project activities, ensuring alignment with KQI (Key Quality Indicators) and KPI (Key Performance Indicators).
    • Serve as a single point of contact for the PHAD/project team and other stakeholders (e.g., BioPharm, Material Science, CPP).
    • Proactively communicate key issues and critical topics to relevant management levels or project team members.
  • Audit and Compliance Support:

    • Assist in internal and external audits, ensuring no critical findings within assigned projects.
    • Work in compliance with appropriate SOPs, GMP, GLP, QM, HSE, ISEC, and Novartis Guidelines.
  • Team Contribution:

    • Actively contribute to team goals, working to meet overall project objectives.
    • Review and author EC/APS protocols, stability studies, and compatibility study plans.

Minimum Requirements:

  • Educational Background:

    • Up to 10 years of relevant experience with an M.Pharm or M.Sc., or at least 4 years of experience with a Ph.D. in a related field.
  • Technical Experience:

    • Desirable knowledge of the site language.
    • Experience in testing Solid Oral Dosage Forms.
    • Expertise in analytical techniques such as dissolution method development, titration, stability studies, LC method development, DVS, forced degradation, and excipient compatibility.
  • Skills:

    • Strong presentation and scientific/technical writing skills.
    • Excellent communication skills for collaborating with internal and external teams.