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    Functional Lead- Cell Line Development

    Lambda Therapeutic Research
    3+ years
    Preferred by Comapny
    Ahmedabad
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Functional Lead - Cell Line Development

    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA). With over 1500 employees, Lambda has provided comprehensive clinical trial solutions for over 20 years. Known for its innovation, Lambda supports the biopharmaceutical and generic industries in developing safe, effective, and high-quality products.

    At Lambda, we believe in hiring the best to achieve the best. We are always seeking qualified and energetic individuals who are passionate about excellence to join our team.

    Position Overview

    The Functional Lead - Cell Line Development will lead the Cell Line Development function within the Process Sciences group. This role requires the candidate to leverage their technical expertise to oversee a team focused on cell line development for monoclonal antibodies (mAb) using CHO (Chinese Hamster Ovary) or murine myeloma cell lines as expression systems. The role also offers an added advantage for candidates with experience in protein bio-therapeutics using bacterial and yeast expression systems.

    Key Responsibilities

    Technical Leadership & Development

    • Provide technical leadership to the cell line development and clone engineering team.
    • Have significant expertise in developing GMP cell banks for process development.
    • Deliver robust clones for process development, ensuring successful production of high-quality monoclonal antibodies.

    Team Collaboration & Vendor Interaction

    • Collaborate closely with the cell culture team for transferring clones to the process development stage.
    • Interact with vendors licensing mammalian cell line technologies for monoclonal antibody product development.
    • Continuously assess new technologies aimed at developing higher productivity cell lines and explore newer technologies for single-cell isolation of lead clones.

    Regulatory Compliance & Technical Documentation

    • Stay updated with the latest regulatory requirements for cell line characterization.
    • Defend the cell line development processes, especially regarding single-cell cloning, to meet regulatory standards.
    • Responsible for authoring and reviewing technical reports, cell line development protocols, and cell banking protocols.
    • Contribute to regulatory submissions, supporting IND enabling data for early-stage clinical trials.

    Best Practices & Team Development

    • Identify and communicate best practices within the CDMO (Contract Development and Manufacturing Organization) function.
    • Develop and maintain a highly capable and dedicated technical team.
    • Guide subordinates in their professional development, offering mentorship and support.

    Experience & Qualifications

    Experience

    • 6 to 8 years of experience with PhD in Biochemistry/Microbiology or 8 to 10 years with an MSc in Biochemistry/Genetics/Microbiology, focusing on mammalian cell line development in biopharma/biotech or relevant contract research labs.
    • Experience in leading a team focused on mammalian cell line engineering and development is highly preferred.

    Educational Qualifications

    • PhD in Biochemistry/Microbiology (6-8 years of experience)
    • OR MSc in Biochemistry/Genetics/Microbiology (8-10 years of experience)

    Key Competencies

    • Accountability: Take responsibility for all technical outcomes and ensure team performance aligns with organizational goals.
    • Communication: Excellent communication skills for interacting with internal teams and external vendors.
    • Leadership: Strong leadership capabilities in managing and mentoring a technical team.
    • Initiative: Proactive approach to identifying new technologies and solutions.
    • Work Ethic: Commitment to delivering quality and consistency in research.
    • Flexibility/Planning & Organizing: Effective in organizing resources, managing time, and adapting to evolving project needs.
    • Motivation: Self-driven with a strong desire to achieve results and contribute to the organization’s success.
    • Technical Knowledge: Expertise in mammalian cell line engineering, cell culture technologies, and related biotech processes.

    Why Join Lambda Therapeutic Research?

    Lambda Therapeutic Research Ltd. offers a dynamic and challenging work environment, ideal for those passionate about cutting-edge clinical research. By joining the team, you will contribute to innovative biopharmaceutical developments, working alongside global experts in the industry.

    Lambda Therapeutic Research Ltd.

    Become part of a global leader in clinical research and help advance the future of medicine through innovative therapies and high-quality research.

    This role provides an excellent opportunity for professionals seeking to apply their technical expertise and leadership skills in a fast-paced and impactful environment.

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