Principal Scientist I, Microbiologist

Key Responsibilities:

• Provide technical leadership and support the Manager in oversight of the QC Microbiology team.
• Lead aspects of critical utilities, environmental monitoring programs, and microbiological testing for water, raw materials, in-process samples, and product release testing.
• Establish, manage, and continuously improve site environmental monitoring and contamination control programs, including risk assessments, routine testing, data trending, interpretation, and excursion management.
• Lead investigations, change controls, and improvement initiatives related to environmental control and contamination risks, working closely with Manufacturing, Engineering, Validation, and Quality stakeholders.
• Establish and maintain microbiology testing and qualification capabilities; serve as QC SME for microbiological assays, methods, and emerging technologies.
• Provide expert input on data review, investigations, and quality decisions; lead or support client discussions related to microbiology, EM, and quality investigations.
• Support the QC Manager in supervising, planning, and reviewing of daily operations of assigned staff, including work allocation, scheduling, training, performance evaluation, and talent development.
• Ensure laboratory activities and assays are executed in compliance with cGMP, GDP, CFR, PIC/S guidelines, and company SOPs, including critical review and approval of data and reports.
• Author, review, and approve SOPs, validation and qualification documents, specifications, investigations, and quality records; guide teams in deviation, OOS, OOL, and CAPA management.
• Provide operational, technical, and administrative leadership to the Microbiology organization, ensuring effective resource utilization and team performance.
• Collaborate with management to plan and manage manpower, laboratory supplies, and equipment budgets.
• Drive implementation and continuous improvement of QC microbiology processes, focusing on efficiency, compliance, and inspection readiness.
• Ensure effective communication and documentation with internal and external stakeholders, including project teams, clients, and auditors.
• Support additional tasks or strategic initiatives assigned by the QC Manager to advance departmental and site objectives.

Requirements:

• Bachelor’s Degree in Microbiology, Chemistry, Biology, Biotechnology, Life Sciences or equivalent
• Minimum of 6 years of experience working in a GMP laboratory environment in the biopharmaceutical or medical devices industry
• Proficient with PICS, ICH, FDA, EMA, NMPA, WHO guidelines and US/Eur. pharmacopoeias.
• Proficient in Quality Risk Management process
• Skilled in laboratory systems and Quality Management Systems
• Knowledgeable in lean six sigma principles
• Previous laboratory supervisory roles and knowledge in ADC manufacturing is an advantage