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Microbiology Manager

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)
• Other duties, as assigned.

Education:

• Master's degree, Bachelor's degree, or additional equivalent experience.

Experience:

• 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.
• 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.
• Ability to always portray an appropriate level of integrity and professionalism.
• Ability to communicate effectively with management, staff, regulators, and client representatives, in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Proficiency in both written and verbal communication and presentations
• Energetic, self-motivated, 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.
• Ability to work closely with a diverse customer and employee base (internally and externally).
• Ability to work well in a cross-functional team environment.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
• Must communicate fluently in English and have legible handwriting.

Preferred Qualifications:

• A.S. in a life sciences discipline and 15+ years of relevant experience working in QC Microbiology
• B.S in a life sciences discipline and 10+ years of relevant experience working in QC Microbiology
• M.S. in a life sciences discipline and 10+ years of relevant experience working in QC Microbiology

Physical Requirements:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

All job requirements in the job description provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations.

Printed Name: ____________________________ Employee Signature: ___________________

Date: ______________________________

The pay range for this role is $81,400 - $146,500. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity. As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.

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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.