Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose Statement
Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments, or equipment.
Support and lead operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
Major Responsibilities:
To perform functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials
Use sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment and determine and may assist in developing methods and procedures to control or modify the manufacturing process
Responsible for Cell culture (from vial thaw to production scale), Buffer/ media preparation, column chromatography, tangential flow filtration and sampling of in process and raw materials.
Assigns tasks within the shift team to other biotechnologists
Assists Supervisor in planning and leading area activities to ensure adherence to schedule
Is involved in regulatory/internal audits and inspections
Is involved in cross-functional meetings
Initiates Demand Work Order
Reviews executed batch records and worksheets
Drives the resolution of anomalous processing events
Sets a positive team environment and inculcates a nurturing AbbVie culture
Acting Supervisor when Supervisor is not available
Qualifications
Bachelor of Science with at least 4 years of experience working in Biologics Production facility or equivalent
Experience should include 3+ years of area/stream specific experience.
As a highly skilled specialist, contributes to the development of concepts and techniques.
Completes complex tasks in creative and effective ways.
Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues.
Makes recommendations for new procedures.
Acts independently to determine methods and procedures on new assignments.
Assists Supervisor in planning and leading area activities.
Shift work is required
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
