Performs biologics manufacturing operations in a cGMP production facility, including method transfer, equipment setup and calibration, quality testing, process adjustments, documentation, data analysis, and campaign support. Coordinates work across sub-groups, tracks issues, develops solutions to moderate-complexity problems, and ensures compliant execution of production procedures. Requires knowledge of media and buffer preparation, cell culture or biological drug purification, safety and quality systems, cGMP, and technology transfer.
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 DescriptionPurpose Statement
- Performs functions associated with current Good Manufacturing Practices 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.
- Determines and may assist in developing methods and procedures to control or modify the manufacturing process.
Major Responsibilities:
- Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
- Schedules work tasks, with general assistance, to support project and campaign timelines. Drafts moderate scope and complexity documents. Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management.
- Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems.
- Applies knowledge, experience, and technical skills to understand ABC production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.
- Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
- Exercises judgment within defined procedures and policies to determine appropriate action. Discusses action with senior staff.
- Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with subordinates and supervisor.
- Bachelor’s Degree or equivalent required.
- At least 1-5 years relevant experience with good writing skills.
- Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
- Computer proficiency. A working knowledge of safety, quality systems, and current Good Manufacturing Practices is required. Familiarity with tech transfer processes.
- Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain a high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
- Basic understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility.
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
AbbVie Singapore, Singapore, SGP Office
9 North Buona Vista Drive, Singapore, Singapore, Singapore, 138588
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