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.
- Involved in regulatory/internal audits and inspections.
- 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.
- 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.
Qualification and experience
- Bachelor of Science with at least 5 years of experience working in Biologics Production facility or equivalent.
- Experience should include 3+ years of area/stream specific experience.
