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    Functional Lead Microbiology

    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 - Microbiology

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

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with facilities in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA). With over 1500 employees, Lambda has been providing comprehensive clinical trial solutions for over 20 years, ensuring safe, effective, and high-quality product development for biopharmaceutical and generic industries.

    Lambda’s team is built on a foundation of innovation and dedication, and we are always looking for talented individuals to join us in achieving excellence.

    Position Overview

    The Functional Lead - Microbiology will oversee the Microbiology function within Lambda's CDMO (Contract Development and Manufacturing Organization). The candidate will lead a team focused on microbiology for GMP(Good Manufacturing Practices) in the pharmaceutical and biopharmaceutical industries. They will be responsible for leading microbiology assays and method validation used for drug substance (DS) and drug product (DP) batch release. The role requires deep experience in microbiological assays such as environmental monitoring, raw material sampling, MLT (Microbial Limit Testing), BET (Bacterial Endotoxin Test), bioburden, sterility testing, and culturing bacterial strains.

    Additionally, the candidate should possess expertise in GMP workflows for injectables, therapeutic proteins (e.g., mAbs, biosimilars), and must have hands-on experience in regulatory compliance with standards from DCGI (Drugs Controller General of India), EMA (European Medicines Agency), and FDA (Food and Drug Administration). The candidate will also work closely with the Head of Analytical Sciences to develop methods that support manufacturing processes, ensuring product quality and process efficiencies.

    Key Responsibilities

    Microbiology Leadership & Method Validation

    • Lead the Microbiology function and ensure effective implementation of microbiological assays for DS and DP batch release.
    • Oversee the validation of microbiological methods, including sterility, MLT, BET, and bioburden testing.
    • Supervise the preparation of URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for instruments and equipment.

    Quality Assurance & Regulatory Compliance

    • Handle deviations, CAPA (Corrective and Preventive Actions), LIRs (Laboratory Investigation Reports), Change Controls, OOS (Out of Specification), and OOT (Out of Trend) related to microbiology.
    • Ensure adherence to regulatory guidelines including Schedule M (India), USP (United States Pharmacopeia), BP (British Pharmacopoeia), IP (Indian Pharmacopoeia), EP (European Pharmacopoeia), PDA (Parenteral Drug Association), and others.
    • Conduct root cause analysis and troubleshoot microbiological methods faced with challenges in qualification and validation.

    Stability & Documentation

    • Fine-tune microbiology methods and prepare specifications and Standard Testing Procedures (STPs) for regular analysis.
    • Conduct stability sample analysis, compile data, and participate in regulatory submissions and sponsor reviews.
    • Ensure proper documentation control as per regulatory guidelines, maintaining compliance with industry standards.

    Customer & Vendor Management

    • Manage customer relationships and maintain partnerships with CDMO sponsors.
    • Coordinate with suppliers for raw material investigations, raw material changes, and equipment upgrades.
    • Address concerns and identify strategic opportunities in collaboration with sponsors.

    Team Leadership & Development

    • Lead the microbiology team, providing mentorship, and guidance, and ensuring analyst qualification in the microbiology laboratory.
    • Implement training programs and ensure continuous professional development of team members.

    Experience & Qualifications

    Experience

    • 12 to 18 years of experience in the pharma and biopharma industry, with a focus on microbiology for GMP.
    • Strong background in method validation, microbiological testing, and regulatory compliance in pharmaceuticals and biopharmaceuticals.
    • Experience in alliance management or co-development in inter-company collaborations is highly desirable.

    Educational Qualifications

    • Relevant knowledge in inferential or descriptive statistical tools for assessing analytical methods and system suitability.
    • Degree in Microbiology, Biotechnology, or a related field.

    Key Competencies

    • Accountability: Ensure team meets all microbiology-related objectives and responsibilities.
    • Communication: Excellent verbal and written communication for effective collaboration with internal teams and external stakeholders.
    • Leadership: Strong leadership skills in guiding and mentoring the microbiology team.
    • Initiative: Proactive approach to improving microbiology methods and streamlining processes.
    • Work Ethic: A commitment to delivering results and ensuring compliance with industry standards.
    • Flexibility/Planning & Organizing: Ability to manage multiple priorities and adapt to changing needs.
    • Motivation: Self-driven with a focus on team and organizational goals.

    Why Join Lambda Therapeutic Research Ltd.?

    Lambda offers a dynamic and collaborative work environment where innovation, expertise, and leadership are highly valued. If you are passionate about microbiology in the biopharmaceutical industry and are looking to make an impact in a growing global organization, Lambda is the place to be.

    This position presents an exciting opportunity for experienced professionals in microbiology to take a leadership role in a forward-thinking and globally recognized organization.

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