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Scientist - Process Development

3-5 years
Not Disclosed
10 Jan. 8, 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

Title: Scientist - Process Development (87531)

Location: Bangalore, Karnataka, India
Division: IPD
Employment Type: Permanent

Job Purpose:
To develop, optimize, and execute the process for Active Pharmaceutical Ingredients (APIs), ensuring timely implementation within budget.

Key Accountabilities:

  • Develop API processes in the lab based on literature surveys and API intermediate characterization to ensure quality and on-time implementation.
  • Prepare development reports and Master Process Guidelines (MPG) based on lab work to facilitate the successful transfer of technology to plant operations.
  • Conduct Quality by Design (QbD) studies, carryover studies, and identify and synthesize/genotoxic impurities for regulatory compliance, minimizing deficiencies in the Drug Master File (DMF) filing.
  • Support procurement in identifying and finalizing vendors for key raw materials by performing vendor qualification to ensure timely implementation.
  • Ensure compliance with stage gate checklists and milestone meetings to complete the project on time.

Qualifications & Experience:

  • Education: M.Sc. in Organic Chemistry.
  • Experience: 3-5 years of experience in process R&D.

Competencies & Skills:

  • Collaboration skills to work effectively in teams.
  • Innovation and creative problem-solving.
  • Accountability in delivering results.
  • Empathy and leadership in team management.
  • Agility to adapt to changing conditions.
  • Strong domain knowledge in process development.
  • Effective people management.

Job Location: Bangalore

Shift Hours: As per project requirements.