Microbiology Manager

Piramal Enterprises Ltd.•Lexington, KY

32d

About The 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

Requirements

Bachelor of Science in Microbiology, Biology, Life Sciences, or related scientific discipline.
4+ years of experience managing high throughput Microbiology Laboratories
5 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment)
Prior management/supervisory experience in a laboratory 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.
Knowledge and understanding of cGMPs; Knowledge of cGMP validation requirements and techniques
Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
Experience managing direct reports
Proficiency using Microsoft Office applications

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 on a daily basis
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)