Analyst (Bioanalysis Of Ba/Be Studies Of Biologics/Biosimilar) (Research Associate)

Lambda Therapeutic Research

3-4 years

Not Disclosed

Ahmedabad

10 Aug. 13, 2024

Job Description

Job Type: Full Time Education: M.Sc. in Biotechnology/Biochemistry 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:

Lambda Therapeutic Research Ltd. is a global Contract Research Organization (CRO) specializing in conducting clinical trials.

Job Details:

Position: Analyst (Bioanalysis of BA/BE Studies of Biologics/Biosimilars)

Key Deliverables:

Develop and validate Ligand Binding Assay (LBA) based bioanalytical pharmacokinetics (PK) methods.
Analyze serum samples from pre-clinical and clinical studies following draft/method SOPs.
Independently execute ELISA and ligand binding assays.
Desirable: Knowledge in PK and immunogenicity method validation.
Accurately and contemporaneously record data.
Compile, analyze, and interpret project data, method development (MD), and method validation (MV) data.
Write reports, SOPs, and plans.
Assist in root cause analysis or investigations for non-conformities and deviations.
Assist in the reconciliation and archival of study and validation raw data.
Manage inventory for critical reagents, general reagents, and consumables.
Create or revise SOPs for the BA-Biosimilar function.

Allied Responsibilities:

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

Experience:

3 to 4 years of experience in bioanalysis using Ligand Binding Assays (LBA) by ELISA.

Educational Qualification:

M.Sc. in Biotechnology or Biochemistry.

Competencies:

Accountability: Ownership of tasks and responsibilities.
Communication: Effective verbal and written communication skills.
Work Ethic: Reliable and dedicated approach to work.
Initiative: Proactive problem-solving and process improvement.
Leadership: Ability to lead and guide team members.
Technical Knowledge: Expertise in bioanalytical methods and ELISA.
Motivation/Initiative: Drive to achieve results and improve processes.
Interpersonal/Leadership Skills: Ability to build relationships and lead teams.
Presentation/Communication Skills: Skill in presenting and communicating information.
Organizational Culture Fit: Alignment with company values and culture.
Flexibility/Planning & Organizing: Adaptability and efficient task management.

Accomplishments & Strengths:

Proven achievements and strengths in method development and validation, as well as effective project management and data analysis.

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Analyst (Bioanalysis Of Ba/Be Studies Of Biologics/Biosimilar) (Research Associate)

Job Description

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