Job Title: Scientist I, Upstream Manufacturing
Job ID: 169095BR*
This position requires routine hands-on bioprocess manufacturing within a current good manufacturing practices (cGMP) cleanroom commensurate with the individual's level of technical expertise, training, and qualification closely following defined procedures. Responsibilities include performing bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation, monitoring of processing equipment, processes, and control systems within a GMP cleanroom for the manufacture of viral vectors.
*What will you do as a Scientist in Manufacturing? *
GMP Production (50% of time spent on floor)
* Lead GMP production activities by acting as process/equipment subject matter expert (SME) on the production floor.
* Ensure that operations are performed as dictated by the relevant associated procedures.
* Ensure on-the-floor documentation follows cGMP standards.
* Coordinate with the other manufacturing departments as needed to ensure required personnel are present for GMP operations.
* Perform timely investigations of deviations as/if they occur.
GMP Production Run Readiness (45%)
* Author and revise client-specific manufacturing batch records.
* Author and revise manufacturing standard operating procedures (SOPs) and work instructions (WIs)
* Work closely with the upstream process development department (USPD) and the client to ensure successful tech transfer of production procedure into the GMP documentation.
* Work closely with USPD and the Facilities department (FA) to identify equipment required for GMP processing and ensure it is present, calibrated/validated, and operational for scheduled GMP operations.
* Work closely with the supply chain department (SC) to identify client-specific required raw materials, place purchasing orders, and place internal material requests to have them delivered to USMFG on schedule for hands-on GMP production activities.
* Investigate, author, and close open deviations, planned variances, and corrective actions/preventative actions (CAPAs).
* Review completed USMFG batch records for accuracy and completeness.
* As Assigned
* High School Diploma and 5+ years of relevant proven experience or superior demonstration of skill sets or background
* Bachelor's Degree in related field and 2+ years of relevant proven experience or superior demonstration of skill sets or background
* PhD in related field and 0+ years of relevant proven experience
*Knowledge, Skills, Abilities*
* Intermediate understanding of Drug Product manufacturing and general Good Manufacturing Practices (cGMP).
* Excellent interpersonal skills.
* Proficiency in Microsoft Word, Excel, PowerPoint, etc.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit [www.thermofisher.com](http://www.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