Manager of Microbiology

Scope of Position

The Microbiology Manager provides oversight of activities related to microbiological testing of bulk and finished products, packaging materials, scale-up samples, process validation samples, marketed stability samples, development, and investigational samples.

Responsibilities

• Effectively mentor and manage the Microbiology analysts in the laboratory.
• Provide and/or manages cGMP and safety training to the Micro staff.
• Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries.
• Develop/implement procedural guidelines within the Microbiology lab in conjunction with Quality Assurance
• Conduct or manage the performance of method and equipment validation/qualification exercises.
• Write necessary protocols, analyze data, and compile final reports for methods and equipment protocols.
• Establish, implement, and manage Lab Programs and/or Policies, SOPs, and good record keeping practices.
• Ensure that all equipment in the microbiology laboratory is functional and in a calibrated state.
• Troubleshoot equipment and methods and communicate with vendors and outside contract laboratories.
• Train analysts in laboratory practices and standard microbiological procedures
• Manage and ensure that smooth function of the laboratory daily activities, including organizing the frequency of testing and prioritizing workload daily.
• Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators.
• Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing, and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
• Establish short and long-range plans for the timely and efficient execution of the microbiological testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
• Ensure Lab Sustain Permanent Inspection Readiness (PIR)
• Perform other duties as assigned.

Qualifications

• Bachelors degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Preferred 15+ years relevant work experience in Quality Control laboratories
• Preferred three to five (3-5) years of leadership/ supervisory experience in commercial laboratory operations.
• 5 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)
• Possess excellent technical writing and oral communication skills.
• SME as it relates to Micro Lab Operations, EM, SAL and the following pharmaceutical Industry guidelines, standards, and statutes: ISPE (International Society of Professional Engineers) guidelines ,FDA and PDA Parenteral Drug Association guidelines, cGMP pharmaceutical industry standards for cleaning, sterilization, and environmental monitoring and control, US Code of Federal Regulations, Titles 210 and 211, US Pharmacopoeia methods and general information chapters related to sterility assurance.
• Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
• Strong experience with project and people management.
• Able to administer personnel performance evaluations.
• Demonstrate the ability to write and understand technical information and produce detailed reports.
• Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding on current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.