Biotechnologist III (Central Services)
Job Summary
Purpose 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.
Qualifications :
- Bachelors 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.
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more