About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose

Senior leader in the QC microbiology laboratory responsible for performing, leading, analyzing, and/or documenting microbiological testing within a GMP environment in support of raw materials, in-process materials, finished products, environmental monitoring, sterility assurance, validation, and other microbiological processes. Uses scientific education and/or experience to generate accurate results in accordance with GMP, procedural requirements, and microbiological principles. Interprets and evaluates microbiological data to determine conformance with product and material specifications, including identification of trends in bioburden, microbial recovery, environmental monitoring results, and sterility-related outcomes. Reviews and verifies data generated by others to ensure compliance with specifications and laboratory expectations. Understands internal business processes to appropriately prioritize assigned work and guide others in the laboratory. Has experience and command of multiple microbiological laboratory techniques to perform them with minimal error. Trains other laboratory personnel on microbiological techniques currently included in their training matrix.

Responsibilities

• Leads and influences analysts in the QC microbiology laboratory with their tasks and activities.
• Understands, implements, and maintains GMP with respect to microbiological laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain and strengthen procedural requirements and microbiological control strategies.
• Performs, leads, analyzes, and/or documents microbiological test methods as written to support product and material release with minimal error.
• Proposes and implements changes to improve microbiological techniques, controls, and laboratory methodology.
• Independently troubleshoots and resolves microbiological assay, technique, contamination, and instrument issues.
• Interprets microbiological and experimental data for conformance with product and material specifications.
• Understands and identifies laboratory technique and instrument performance in accordance with microbiological and scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements, including deviations, atypical results, OOS/OOT investigations, and contamination events as applicable.
• Implements and ensures improvement ideas are completed to facilitate team objectives. Proposes and implements scientific protocols to determine root cause of exception events.
• Supports or leads investigations related to environmental monitoring excursions, sterility failures, bioburden excursions, microbial identification trends, and aseptic process-related issues.
• Participates in or supports aseptic simulation validations and other microbiological validation activities as needed.

• Required - BS degree in Science or equivalent
• 10+ years of relevant experience
• Maintains their certifications as needed for assigned job tasks.
• Demonstrates strong analytical skills and logical thought process.

Preferred Qualifications:

• Experience with aseptic simulation validations
• Experience with environmental monitoring, bioburden, sterility testing, microbial identification, or contamination investigations
• Experience supporting aseptic processing or microbiological validation activities

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html