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Lead Quality Control CAR T

3 months ago


Bengaluru, Karnataka, India Dr Reddy's Laboratories Limited Full time
Quality Control Lead - Exciting Opportunity

Job Description:

We are looking for a dedicated individual to join our team as a Quality Control Lead for Cell therapy products. As a pivotal member of the Quality Control team, you will be responsible for ensuring the highest quality standards of our products. Your role will involve managing a team of QC specialists, overseeing the testing of various products, and ensuring compliance with regulations.

  • Lead the QC Cell therapy team in utilizing a variety of analytical methods such as Flow Cytometry and Molecular Assays to maintain quality standards.
  • Coordinate project planning, communication, and risk management activities to ensure efficient workflow.
  • Contribute to strategic planning for the CAR-T functional area and implement department strategies.
  • Establish effective relationships with business partners and stakeholders to align objectives and deliver results.
  • Proactively identify areas for improvement and implement organizational enhancements.
  • Provide technical support for manufacturing and QA teams, ensuring smooth process transfers and addressing any issues that may arise.
  • Participate in regulatory filings and submissions, contributing technical expertise to support approvals.
  • 2+ years of experience in product ownership within a lab environment is preferred.
  • Contribute to the design and execution of comparability assessments for cell therapy products.
  • Review and summarize technology transfer strategies for regulatory filings.
  • Collaborate with various stakeholders to align strategies across functions.

Experience and Technical skills required

  • Expertise in global cell therapy and logistics, facility architecture, and automation.
  • Prior experience in Human cell handling, Gene therapy processes, and regulatory compliance.
  • Proficiency in LIMs and SAP systems is advantageous.
  • Knowledge of DoE study design and quality management processes.
  • Experience leading quality inspections and interacting with regulatory agencies.
  • Strong leadership and project management skills are essential for this role.

Behavioral skills:

  • Leadership: Lead a team effectively to achieve departmental goals.
  • Communication: Ensure clear communication for efficient workflow.
  • Problem-Solving: Analyze complex issues and develop effective solutions.
  • Decision-Making: Make timely decisions to address challenges.
  • Teamwork: Collaborate with colleagues to achieve common objectives.
  • Time Management: Prioritize tasks and meet deadlines effectively.

Qualifications:

  • Ph.D., Master's, or Bachelor's degree in relevant fields with experience in Cell and Gene therapy.