Analytical Technology Specialist

AbbVie Inc.; Kansas City (MO); On-site; USD 65,000 - 95,000; Full time

Job summary

AbbVie in the United States seeks a QC Bioassay Specialist to support timely, compliant drug product testing and investigations in a GMP environment. You will perform release and stability analyses, document results, and maintain laboratory data integrity.

The role involves contributing to reagent qualifications, equipment maintenance, root cause investigations, and interpreting results per established standards, with opportunities to develop methods and support critical projects.

Qualifications

• Bachelor of Science in a biological field preferred.
• GxP experience preferred but not required.
• Solid understanding of ELISA-based methods.
• Knowledge of HPLC and UV techniques preferred.
• Experience with method development and validation is a plus.
• Lab experience with mammalian cell culture is advantageous.

Responsibilities

• Perform QC release analysis of commercial finished product per schedule and regulations.
• Perform QC stability analysis per schedule and regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously.
• Adhere to safety, housekeeping and quality standards; notify management of discrepancies.
• Support routine lab duties such as reagent qualifications, inventory, and equipment maintenance.
• Assist with Root Cause Analysis investigations as required.
• Develop proficiency in QC Bioassay IT systems.
• Review and interpret test results according to established standards.

Skills

Data Integrity

Communication

Time management

Teamwork

Problem solving

Technical writing

Education

Bachelor of Science

Tools

HPLC

UV

ELISA

Job description

Company Description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The role supports the timely and compliant delivery of commercial drug product testing and ad hoc investigation and development testing in accordance with approved procedures, GMP and applicable regulatory requirements. As a member of the laboratory team the incumbent will be required to demonstrate the prescribed laboratory values and standards and escape any technical or quality matters appropriately. The position may also contribute to critical reagent screening and qualification, laboratory housekeeping, documentation review, procedural updates, investigations, and the execution or support of analytical method transfers and validations based on training and demonstrated skill level.

• Perform QC release analysis of commercial finished product as per schedule and in accordance with regulatory requirements.
• Perform QC stability analysis as per schedule and in accordance with regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously, accurately and legibly.
• Adherence to all company standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies.
• Contribute to routine lab duties such as critical reagent qualifications, inventory management and equipment maintenance.
• Support Root Cause Analysis investigations where required.
• Develop proficiency in all laboratory IT systems required by QC Bioassay
• Develop the skills required to review and interpret test results via established standards and requirements.

Qualifications

Education and Experience

• Minimum requirement of Bachelor of Science. Qualifications in a biological field are preferable.
• Previous GxP experience is preferable but not required.
• Sound scientific/practical understanding of ELISA based methods.
• Knowledge and practical experience in HPLC and UV techniques is preferable.
• Knowledge of method development and validation preferable.
• Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage.

Key Skills, Experience, and Competencies

• Knowledge and understanding of Data Integrity from Laboratory perspective.
• Excellent communication, organization, time management and teamwork skills.
• Basic statistical knowledge is advantageous.
• Proven ability to work on one’s own initiative with a focus on Right First Time (RFT).
• Ability to solve problems through timely communication and collaboration.
• Technical writing ability.
• Demonstrated ability to support priority projects to meet timelines

Additional Information

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, visit https://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