Manager/Senior Manager - Quality Control - Bioassay & Molecular

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Job Summary

lead and supervise Bioassay & Molecular Biology laboratory operations

Key Responsibilities

1. Laboratory Operations & Technical Leadership

• Lead and supervise

  daily QC Bioassay & Molecular Biology laboratory operations

  .
• Oversee

  routine testing, method transfer, and validation

  of:
• Bioassays (cellbased potency assays, binding assays, etc.)
• Molecular biology methods such as

  ELISA, qPCR, RTPCR, sequencing, residual DNA analysis, plasmid characterization, and host cell impurity testing

  .
• Monitor laboratory performance metrics including

  turnaround time, efficiency, and resource utilization

  .
• Ensure

  method lifecycle management

  in line with

  ICH Q2/Q14

  and regulatory expectations.

2. Troubleshooting & Analytical Investigations

• Optimize assay performance to ensure

  robustness, reproducibility, and reduced variability

  .
• Act as

  Subject Matter Expert (SME)

  for complex:
• Analytical investigations
• OOS / OOT / OOE troubleshooting
• Perform

  root cause analysis (RCA)

  and implement effective

  CAPAs

  .
• Handle

  analytical method queries and information requests (IRs)

  from regulatory agencies.

3. Data Review, Documentation & Quality Systems

• Ensure

  data integrity and ALCOA+ compliance

  across all QC activities.
• Review and approve

  SOPs, protocols, validation reports, investigation reports

  , and regulatory support documents.
• Drive

  continuous improvement initiatives

  , including:
• Process optimization
• Digitalization and automation
• Advanced data management practices

4. Compliance & Regulatory Readiness

• Ensure compliance with

  cGMP, ICH guidelines

  , and

  pharmacopeial standards (USP / EP / JP / WHO)

  .
• Support and lead

  internal and external audits

  .
• Face and respond to

  global regulatory inspections

  (USFDA, EMA, etc.) with strong technical justification.

5. Team Development & Sample Management

• Train, mentor, and evaluate

  QC analysts and technicians

  .
• Ensure competency in

  analytical techniques, documentation, and data integrity

  .
• Oversee

  sample management

  , including receipt, storage, traceability, and handling of biological materials.

6. CrossFunctional Collaboration

• Coordinate with

  QA, Manufacturing, R&D, and Regulatory Affairs

  teams to resolve quality and compliance issues.
• Support biosimilar development and commercial activities from a QC standpoint.

Behavioural Competencies

• Strong

  leadership and decisionmaking skills

• Excellent

  communication and stakeholder management

  abilities
• High accountability with a

  problemsolving mindset

• Strong attention to detail and quality focus

Qualifications & Experience

• Education:

  Masters degree in

  Biotechnology / Biochemistry / Microbiology

• Experience:

  14 18 years in

  QC Bioassay / Molecular Biology

  within a regulated biopharmaceutical environment

• Mandatory:

  Handson experience in

  Biosimilars

• Added Advantage:

  Experience in

  Physicochemical / Chromatography methods