Scientist, Microbiology Data Reviewer
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
This Quality Control Scientist, Microbiology Data Reviewer is a subject matter expert on review of documentation associated with the operation of a cGMP QC microbiology laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the microbiology laboratory supporting batch release, environmental monitoring, cleaning verification, raw materials release and compendial method suitability activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within scope.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Reviews cGMP microbiology data generated during testing to support facilities monitoring and product release using the Bioburden and Endotoxin methods. Ensures that standards for documentation and reporting of data comply with SOPs (analytical methods and Good Documentation Practices) and industry standards.
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards. A minimum of three years of QC microbiology laboratory experience is preferred.
• Provides timely and thorough review of laboratory logbooks, labeling and other documentation to verify completeness, accuracy and conformance with company SOPs and industry guidelines. Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
• Reviews protocols, analytical reports and certificates of analysis. May compile and summarize analytical raw data in various physical and electronic report formats.
• Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
• Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
• May coordinate and track progress of analytical testing internally or at CROs.
• May participate in regulatory agency audits and inspections.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
• Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
• Ability to operate independently where appropriate, yet escalate issues as appropriate, establishes effective cross functional working relationships.
• Strong attention to detail is essential. Well-developed organizational, interpersonal communications, writing, and strong listening skills are required.
• Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
• Must be able to recognize the impact beyond a single site, project or collaboration.
• Must have strong verbal, technical writing and presentation skills.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• PhD. degree in Microbiology, Biology, Molecular Biology or a related field and three (3) years, or M.S. degree and five (5) years of relevant experience in analytical development for biotherapeutics.
• Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
• Three to five years of experience with development and application of analytical methods commonly applied to release of biopharmaceuticals proteins (monoclonal antibodies and antibody drug conjugates), raw materials.
• Experience in pharmaceutical and biotechnology product development preferred.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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