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In Vivo Pk Scientist

5-8 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: In Vivo PK Scientist

Job Location: Bangalore
Date: 16 Jan 2025
Experience Required: 5-8 years post-qualification
Educational Qualification: M. Pharm or M.V. Sc. (Pharmacology & Toxicology)


Job Purpose:

The In Vivo PK Scientist is responsible for conducting pharmacokinetics (PK) studies in rodents, ensuring proper documentation, data analysis, and compliance with safety and regulatory guidelines. The role requires expertise in surgical procedures, biological sample collection, and pharmacokinetic data analysis, contributing to the successful execution of preclinical drug development studies.


Key Responsibilities:

1. Pharmacokinetic Studies & Surgical Procedures:

  • Conduct PK studies in rodents, ensuring accuracy and efficiency.
  • Perform surgical procedures such as cannulation of jugular, femoral, and portal veins in rats.
  • Conduct chronic bile duct cannulations and work with various animal models for in vivo PK studies.
  • Collect biological fluids (e.g., cerebrospinal fluid, bile, urine, synovial fluid lavage) and vital organs for tissue distribution studies.

2. Documentation & Compliance:

  • Prepare study protocols and reports for IND/NDA submissions.
  • Maintain online lab notebooks and ensure proper compound management.
  • Adhere to regulatory guidelines for drug metabolism and pharmacokinetics.

3. Data Analysis & Formulation Understanding:

  • Analyze pharmacokinetic data using Phoenix WinNonlin and other analysis tools.
  • Understand ADME assays and their correlation with PK parameters.
  • Possess basic knowledge of formulations used for pharmacokinetics, efficacy, and toxicity studies.

4. Environment, Health, and Safety (EHS) Compliance:

  • Follow all EHS guidelines to ensure personal and team safety.
  • Participate in safety training and adhere to workplace safety protocols.
  • Promote a culture of safety and regulatory compliance within the team.

Technical/Functional Skills:

  • Expertise in in vivo pharmacokinetic studies.
  • Proficiency in surgical techniques (jugular, femoral, portal vein cannulation, bile duct cannulation).
  • Experience in biological fluid and tissue collection for PK and tissue distribution studies.
  • Ability to analyze pharmacokinetic data using Phoenix WinNonlin and other software.
  • Understanding of ADME assays and regulatory guidelines for drug metabolism and pharmacokinetics.

Behavioral Skills:

  • Strong team player with a willingness to take on challenges.
  • Commitment to work and ability to meet strict timelines.
  • Enthusiastic and hardworking with a continuous learning attitude.
  • Good communication skills for collaboration and reporting.

Syngene Values:

All employees are expected to demonstrate Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer Statement:

Syngene is committed to providing equal employment opportunities (EEO) to all individuals, regardless of age, gender, race, nationality, disability, or other protected characteristics. Reasonable accommodations will be provided for qualified individuals with disabilities.