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Form of workJob Description
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
How will you make an impact?
The candidate is in charge of the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) and Downstream (purification) Biopharmaceutical Manufacturing. These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
What will you do?
· Maintain safe and clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.
· Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.
· Able to complete all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
· Acts as On-The-Job-Trainer for a variety of job functions
· Documentation of all activities to meet cGMP requirements. Complete document reviews and revisions. Daily record review, tasks, and databases. Actively document feedback.
· Critical evaluation of processes, including foresight and thinking ahead.
· Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
· Complete production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results.
· Perform timely consumption of materials and completion of quality documentation in appropriate systems
· Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. Work to complete documentation of deviations and events in appropriate systems
· Complete validation protocols with minimal supervision or direction
· Participate in cross-functional teams to complete projects
· Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.
How will you get here?
· High school degree required. Bachelor’s degree in science or engineering preferred.
· 3+ years of proven experience in a related field or industry required
· Experience in GMP environment preferred
Knowledge, Skills, Abilities
· Understanding ‘why’ and not just the ‘how’ of processes and practices
· Knowledge of cGMP practices required
· Knowledge of deviation investigations preferred
· Knowledge of chromatography, cell culture, and aseptic techniques strongly preferred
· Mechanical Skills/ Analytical Skills/Method Automation
· MS Office
· Strong math skills
· Strong prioritization skills
· Detail oriented
· Results driven
· Able to read, write, and communicate in English
· Able to understand and carry out instructions
· Reliable
· Strong communication (written and verbal)
· Effectively multi-task
· Able to work in an environment of change
· Able to work independently and as part of a team
· Able to recognize problems developing, not just occurring
· Ability to lift minimum of 25 lbs independently
· Ability to stand for 80% of shift
· Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
