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Head Microbiology

20+ years
Not Disclosed
10 Jan. 3, 2025
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

Title: Head of Microbiology
Location: Bangalore
Date: 2 Jan 2025

Job Description:

Job Title: Head of the Department (HOD)
Location: Bangalore

About Syngene:

Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services, ranging from early discovery to commercial supply.

At Syngene, safety is integral to all aspects of our operations, both personally and professionally. We prioritize safety alongside business performance, with shared responsibility and accountability, ensuring compliance with safety guidelines, procedures, and SOPs in all activities.

Core Responsibilities:

  • Provide coaching on compliance with cGMP, GDP, GLP procedures, and Data Integrity policies. Serve as the subject matter expert for clients, regulators, and Syngene staff on projects and proposals.
  • Ensure that laboratory employees are trained and qualified for their designated tasks.
  • Monitor laboratory operations to ensure compliance with SQDEC parameters, regulatory requirements, and industry best practices.
  • Lead and monitor laboratory activities to reduce errors, increase productivity, and maintain an audit-ready status for internal, client, or regulatory inspections.
  • Address and resolve audit observations promptly and effectively, ensuring compliance with CAPA (Corrective and Preventive Actions).
  • Manage laboratory budgets and prepare annual reports for management and stakeholders.
  • Ensure effective communication with clients and cross-functional teams (CFT).

Key Accountabilities:

  • Lead and mentor the QC microbiology team, driving Syngene’s core values: Excellence, Integrity, Professionalism.
  • Ensure laboratory operations align with regulatory guidelines and quality standards.
  • Identify improvement opportunities in procedures, infrastructure, and practices to meet regulatory requirements and industry standards.

Experience and Skills:

  • 20+ years of experience in Biotechnology, Pharma (R&D, API's, Formulations), Pharmaceutical, CRO, or CDMO industries.
  • Proven ability to lead projects and manage cross-functional teams with multiple stakeholders.
  • Expertise in microbiology, QC, injectables, and sterile environments.
  • Excellent communication and interpersonal skills, with the ability to manage client relationships and lead projects effectively.
  • Proficient in MS Office and MS Projects.

Education:

  • M.Sc or M.Pharma

Equal Opportunity Employer:

Syngene is committed to providing equal employment opportunities to all individuals, irrespective of age, color, nationality, disability, gender, or any other characteristic protected by law. We also offer reasonable accommodations for individuals with disabilities.