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Bioassay Analyst

3-6 years
Not Disclosed
10 Jan. 30, 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: Bioassay Analyst

Job Location: Bangalore
Department: Quality Control - Biologics
Designation: Senior Executive, IPQC
Experience Required: 3-6 years


About Syngene

Syngene International Ltd. (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery to commercial supply. The company upholds safety, quality, and compliance as fundamental priorities in all operations.

Commitment to Safety & Compliance

All employees at Syngene must:

  • Follow safety guidelines, SOPs, and regulatory requirements.
  • Maintain environment, health, and safety (EHS) compliance in daily operations.
  • Complete mandatory training on data integrity, health, and safety within assigned timelines.
  • Ensure compliance with Syngene’s quality standards at all times.
  • Support audit preparedness and adherence to CAPAs from previous audits.

Job Purpose

The Bioassay Analyst will be responsible for conducting plate-based and cell-based bioassays, performing in-process, finished product, and stability sample analyses, and ensuring instrument calibration and compliance in a shift-based role.


Key Responsibilities

Bioassay & Analytical Activities

  • Conduct plate-based and cell-based bioassay techniques for biologics testing.
  • Perform in-process, finished product, and stability sample analysis.
  • Operate and maintain analytical instruments and equipment in the QC laboratory.
  • Ensure calibration, preventive maintenance (PM), and troubleshooting of instruments in coordination with vendors.

Compliance & Documentation

  • Adhere to Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs).
  • Ensure error-free analysis and proper documentation of all test results.
  • Maintain audit readiness and support audit preparation activities.
  • Ensure timely completion of Corrective and Preventive Actions (CAPAs) from previous audits.

Laboratory & Equipment Management

  • Monitor and maintain storage chamber temperature limits to prevent deviations.
  • Ensure timely rectification of equipment breakdowns in coordination with service providers.
  • Collaborate with external vendors to ensure on-time calibration and preventive maintenance.

Process Improvement & Team Collaboration

  • Support continuous improvement initiatives in bioassay testing procedures.
  • Assist in training new team members and sharing best practices.
  • Collaborate with cross-functional teams to ensure timely release of samples within turnaround time (TAT).

Leadership & Behavioral Competencies

  • Continuous Learning & Process Improvement
  • Accountability & Integrity in work execution
  • Collaboration within teams and across functions
  • Assertiveness & task ownership while maintaining professional conduct
  • Commitment to excellence and quality standards

Educational Qualification

  • Bachelor’s or Master’s degree in Science (Biotechnology, Bioprocess Engineering, or related field)

Skills & Technical Capabilities

  • Knowledge of biologics manufacturing and testing compliance
  • Proficiency in bioassay techniques (plate-based & cell-based assays)
  • Understanding of quality control and regulatory requirements in biopharma
  • Strong documentation and analytical skills
  • Effective communication and teamwork abilities

Equal Opportunity Employer

Syngene is an Equal Employment Opportunity (EEO) employer, ensuring fair opportunities for all individuals regardless of age, gender, nationality, race, religion, disability, or other protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities.

 

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