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    Manufacturing Specialist (Car-T)

    Dr.Reddy's
    4-15 years
    Not Disclosed
    Bengaluru
    10 Dec. 25, 2024
    Job Description
    Job Type: Full Time Education: PhD/MSc/BSc 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

    Company Description

    Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a global presence. The company is driven by a shared mission to accelerate access to affordable and innovative medicines, as encapsulated in their mantra: Good Health Can’t Wait. With over 24,000 employees worldwide, Dr. Reddy’s focuses on advancing healthcare through a blend of deep science, progressive people practices, and corporate governance.

    Job Description

    Position: Manufacturing Scientist / Senior Manufacturing Scientist (Cell Therapy - CAR-T Programs)

    Dr. Reddy’s Laboratories is seeking Manufacturing Scientists or Senior Manufacturing Scientists for its Cell Therapy (CAR-T) programs within the manufacturing facility. In this role, you will play a pivotal part in supporting GMP Manufacturing operations, Technology transfer, quality assessments, process validation, and supply chain logistics across various novel cell therapy modalities.

    Roles & Responsibilities:

    As a Manufacturing Scientist or Senior Scientist, your typical duties may include:

    • Process Development & Execution: Design and execute experiments to develop robust manufacturing processes for cell therapy products. Support programs through clinical development and commercialization.
    • Team Leadership: Lead and train a team of cell process scientists and engineers, ensuring close collaboration within a highly matrixed, cross-functional team to meet program goals.
    • T-Cell Culture Management: Manage T-cell culture and differentiation processes to support development, characterization, and validation efforts.
    • Troubleshooting: Handle complex troubleshooting scenarios and provide solutions to resolve production or process issues.
    • Documentation & Analysis: Document experimental procedures and results in compliance with established guidelines. Perform statistical analysis of experimental data to define critical process parameters.
    • SOPs & Risk Assessments: Assist in the development of Standard Operating Procedures (SOPs), batch records, and risk assessments. Support technology transfer activities.
    • Batch Review: Review completed production batch records and assist in deviation management, CAPAs, Change Controls, and investigations.
    • Communication & Reporting: Communicate progress against plan, identify business-critical issues, and escalate concerns as necessary, providing solutions or recommendations.
    • Cross-Functional Collaboration: Work effectively with cross-functional teams to drive development activities and resolve challenges. Lead projects and contribute to team discussions.
    • Technical Expertise: Serve as an internal technical subject matter expert, supporting technology transfers and engineering batches.
    • Strategic Roadmap Development: Align with leadership to develop strategies for medium optimization, phase-appropriate development, and implementation.
    • Mentoring: Guide and support junior team members to independently plan and design experiments, fostering scientific growth and critical thinking.

    Qualifications:

    Educational Qualifications:

    • PhD, MSc, or BSc in Biotechnology, Biology, Immunology, Cell Biology, or a related life-science discipline.

    Experience:

    • Manufacturing Scientist: 4-10 years of relevant experience in Cell Therapy or Biologics manufacturing.
    • Senior Manufacturing Scientist: 8-15 years of relevant experience in Cell Therapy or Biologics manufacturing.

    Skills & Expertise:

    • Aseptic Processing: Experience with GMP aseptic processing and cell culture.
    • Cell Culture and Technology: Familiarity with automated equipment for cell culture, washing, and cryopreservation is preferred.
    • Process Development: Experience in the design, execution, analysis, and documentation of T-cell culture processes for biologics or cell therapy products.
    • Collaboration: Ability to work independently and in teams in dynamic, fast-paced environments, managing multiple projects in parallel.
    • Technology Platforms: Experience introducing novel technology platforms into process development and commercial manufacturing.
    • Statistical Analysis: Proficiency in design of experiments (DOE) and statistical analysis methods.
    • GMP Compliance: Working knowledge of GMP regulations and requirements.
    • Decision-Making: Ability to make clear, timely decisions and drive the Manufacturing team towards success.
    • Communication & Organization: Strong verbal and written communication skills, organizational skills, and the ability to meet deadlines and adapt to changing priorities.

    Additional Information:

    Dr. Reddy’s Laboratories offers a collaborative and fast-paced working environment where employees have the opportunity to lead and contribute to critical cell therapy advancements. The company values innovation and is committed to fostering an environment of continuous learning and growth.

    For more information, visit Dr. Reddy’s Careers website.

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