This role will provide technical direction on microbiology requirements and related activities including but not limited to Antimicrobial Efficacy Testing, test method validation/suitability, reduced testing assessments, objectionable microorganism assessments, setting alert/action levels and writing investigations/deviations. This role would support the creation and /or approval of test method validation protocols, reports and test methods for raw materials, finished products, primary packaging components, water, swab recovery and rinse water supporting commercial manufacturing operations for non-sterile consumer products. In addition, a key role would be to provide input into the SOPs /tier documents currently being developed, and then to ensure appropriate implementation. Technical input includes participation on cross-functional teams and other technical groups to ensure product robustness and compliance to internal policies/procedures, and external regulations. The individual in this role will act as SME (Subject Matter Expert) on these teams.
Additionally, this role will support sampling, microbiological analysis to raw materials, work in- process, finished product and utilities monitoring, to ensure that they are within the established parameters. Assists in training new personnel in the laboratory. Performs analysis to identify microorganisms, if required, to ensure that the finished product is free of pathogenic microorganisms. Coordinates and actively participates in validations and qualifications of the laboratory and manufacturing area equipment/processes. Assists the supervisor in the development and revision of operational procedures of the work area. Documents and/or verifies the microbiology data analysis in the official records of the company. Performs safety/environmental audits in the Microbiology Laboratory and submits documentation for the supervisor’s approval. Performs failure investigations to ensure compliance with laboratory processes and/or investigations to rule out laboratory errors. Reviews and approves the documentation required in the laboratory to ensure compliance with company procedures and regulatory agencies. Performs data entry of results and approves analysis in LIMS. Stops product process to its next phase using SAP, when required. Prepares reports related to microbiological analysis, exceeded limit results and monthly metrics. Meets the goals established for the department and promotes teamwork to achieve such. Ensures the work areas remain clean, in order and controlled to comply with the Good Laboratory Practices.
Evening and weekend work might be required
Experience/ Technical Competencies
5+ years Microbiology Experience in Pharmaceutical Industry
• Represent R&D Microbiology on cross-functional teams.
• Plan, schedule, conduct and coordinate research projects.
• Thorough technical knowledge in microbiology.
• Strong problem solving skills.
• Has broad knowledge of the business.
• Ability to perform a wide range of USP and other compendial (e.g. EP, JP etc.) based microbiological procedures.
• Highly experienced within required functional area (e.g. methods development, validation/transfer, stability, raw materials).
• Familiar with GMPs, GLPs, SOPs, and latest regulatory trends.
• Effective oral and written communication skills.
• Ability to write effective test methods, research protocols, reports, memos and e-mails.
• Ability to make effective presentations at team/company meetings.