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Research Associate - Pk / Pd Operations

1-2 years
Not Disclosed
10 Aug. 13, 2024
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

Organizational Overview

Job Details

Job Role: Analyst (BA/BE, Phase I & Phase III Studies)
Reporting To: Head of Department/Project Head
Department: BA-PBS
Location: Ahmedabad
Overall Purpose: Develop and validate LBA-based bioanalytical methods, and independently execute ELISA/ligand binding assays.

Experience: Fresher or a minimum of 1-2 years of relevant experience.

Educational Qualification & Expertise:

  • Degree: MSc in Biotechnology/Biochemistry
  • Skills: Experience with ELISA, MSD, cell culture techniques, and cell-based assays.
  • Knowledge: PK and immunogenicity method validation (desirable).

Key Deliverables:

  • Develop and validate LBA-based bioanalytical methods.
  • Analyze pre-clinical and clinical samples following draft/method SOPs.
  • Serve as study personnel in GLP studies adhering to OECD principles.
  • Ensure accurate execution of method validation and study sample analysis.
  • Record and document data accurately and contemporaneously.
  • Compile, analyze, and interpret data from projects, method development (MD), and method validation (MV).
  • Write reports, SOPs, and plans.
  • Assist with root cause analysis and investigations for non-conformities or deviations.
  • Reconcile and archive study or method validation raw data.
  • Manage inventory for critical and general reagents or consumables.
  • Create or revise SOPs for the BA-Biosimilar function.

Allied Responsibilities:

  • Perform additional tasks as assigned by the Head of the Department or Project Head.

Experience:

  • Fresher or 1-2 years of experience in bioanalytical methods and assays.

Educational Qualification:

  • MSc in Biotechnology/Biochemistry.

Competencies:

  • Accountability: Ownership of tasks and responsibilities.
  • Communication: Effective verbal and written communication skills.
  • Work Ethic: Demonstrates reliability and dedication.
  • Initiative: Proactive approach to problem-solving and process improvement.
  • Leadership: Ability to guide and motivate team members.
  • Technical Knowledge: Expertise in ELISA, ligand binding assays, and cell-based assays.
  • Motivation/Initiative: Drive to achieve results and continuously improve.
  • Interpersonal/Leadership Skills: Ability to build relationships and lead effectively.
  • Presentation/Communication Skills: Skill in presenting data and information clearly.
  • Organizational Culture Fit: Alignment with company values and culture.
  • Flexibility/Planning & Organizing: Ability to adapt and manage tasks efficiently.

Accomplishments & Strengths:

  • Demonstrated success in method development, data analysis, and documentation.
  • Effective management of bioanalytical methods and assays, contributing to high-quality results.