Functional Lead Microbiology

2+ years

Not Disclosed

Ahmedabad

10 Dec. 19, 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.
Date: Dec 16, 2024

Organizational Overview

Lambda Therapeutic Research Ltd. is a global leader in Clinical Research, headquartered in Ahmedabad, India, with additional facilities in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA). With over 1500 employees worldwide, Lambda offers comprehensive clinical trial solutions and has over 20 years of experience in the biopharmaceutical and generic industries. Lambda’s commitment to innovation and quality helps clients develop safe and effective products across various therapeutic areas.

Job Details

Lambda is seeking a highly experienced Functional Lead Microbiology to oversee the Microbiology function within the Contract Development and Manufacturing Organization (CDMO) team. The role requires leadership in microbiology assays and methods validation for drug substance (DS) and drug product (DP) batch releases, particularly for injectable pharmaceuticals and biopharmaceuticals like biologics, mAbs, and biosimilars.

Key Responsibilities

Leadership: Lead the microbiology function within the CDMO department, managing a team focused on GMP microbiology.
Method Validation: Oversee validation of microbiology methods used for batch release and ensure compliance with GMP workflows for pharmaceuticals and biologics.
Microbiological Assays: Lead the execution of key microbiological assays including environmental monitoring, raw material sampling, MLT, BET, Bioburden, sterility testing, and bacterial strain culturing.
Regulatory Compliance: Ensure adherence to regulatory guidelines (DCGI, EMA, FDA) and maintain compliance with OOS, change control, deviation management, and CAPA processes.
Collaboration: Work closely with the Analytical Sciences team to develop methods supporting efficient manufacturing processes and high-quality product development.
Alliance Management: Foster strong relationships with collaborators and sponsors, particularly in inter-company alliances or co-development initiatives.
Troubleshooting and Method Optimization: Provide troubleshooting expertise for microbiology methods and develop corrective actions to address challenges related to qualification/validation.
Documentation: Ensure proper documentation control as per regulatory guidelines (USP, BP, IP, EP, ICH, etc.) and participate in regulatory submissions and sponsor audits.
Training and Development: Lead the training and qualification programs for microbiology analysts, ensuring the team is equipped with the necessary knowledge and skills to perform their roles effectively.

Key Deliverables

Successful leadership of the microbiology function ensuring GMP compliance for microbiological assays and batch releases.
Consistent delivery of high-quality microbiology reports, method validation, and troubleshooting strategies.
Effective collaboration with internal teams and external stakeholders to drive process efficiencies and product quality.
Maintenance of strong sponsor relationships and successful regulatory compliance.

Experience

12-18 years of experience in microbiology within the pharmaceutical and biopharma industry, with leadership experience.
Strong experience in method validation, GMP workflows, and microbiology assays for injectables and biologics.
Expertise in working with regulatory compliance standards (DCGI, EMA, FDA).
Experience in alliance management, co-development, and inter-company collaborations.

Educational Qualifications

Relevant degree in microbiology, life sciences, or a related field.
Familiarity with statistical tools for analytical method robustness and analytical consistency.

Competencies

Strong leadership, communication, and interpersonal skills.
Ability to drive operational efficiency and resource planning.
Strong problem-solving and troubleshooting skills in microbiological testing and methods.
Excellent organizational and planning abilities with a focus on flexibility and adaptability.
Strong technical knowledge and commitment to compliance with industry standards.

Why Lambda?

Lambda Therapeutic Research offers an excellent work environment for professionals looking to lead and innovate in the microbiology space within clinical research and biopharmaceutical development. Join our team to be a part of cutting-edge research and the delivery of high-quality therapeutics worldwide.

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