Vacancy caducado!
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.How will you make an impact?The Scientist will support cGMP manufacturing activities to ensure that Thermo Fisher Scientific Viral Vector Services provides clients with gene therapy products for pre-clinical and clinical use. The incumbent will be the primary point of contact for the Downstream MFG department and lead multiple assigned client projects or programs. Lead hands-on cGMP purification of viral vectors under the supervision of the Downstream Manufacturing Supervisor/Manager. The incumbent will work with the Downstream and Upstream Manufacturing Leads, Supervisors, and Managers. The incumbent will also review executed records related to production activities, assist in writing deviations, investigations, etc. related to cGMP production.What will you do?Production Operations (45%)Lead production suite operations, preparation and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records.
Lead personnel in Downstream specific equipment operation such as:
Chromatography Systems; Single Use and Non-Single Use like:
AKTA systems (AKTA Ready, Process, Pilot, Avant)
Navigate and generate reports with Unicorn 7
Sepragen QuantaSep 2000 SU
Verdot FlexiPro
TFF Systems; Single Use and Non-Single Use like:
Spectrum Systems (Kr2i, KTF, KML)
Homemade setups with TangenX and Sartorius Holders
Hollow Fiber Filters
Flat-Sheet Filters
Millipore Mobius FlexReady
AKTA Flux
Ultracentrifugation Systems;
Continuous and Step Density Gradient Techniques with CsCl
Fraction collection from centrifuge tubes
Beckman Coulter Optima XPN Centrifuge
Zonal Ultracentrifugation (ZUC)
Ensures that downstream manufacturing modules operate efficiently to meet timelines and schedules.
Lead and perform hands-on activities following detailed protocols, batch records, SOPs, job hazard analysis (JHAs), waste streams, risk assessments to complete production runs efficiently, safely, and correctly.
Document all steps in production runs with minimal errors (right-first time).
Lead the review of executed batch records and ancillary production related documents as well as generate run reports for assigned projects.
Lead the writing of deviations, planned variance, change control forms as required for assigned projects.
Organize and coordinate post-run debriefs to review successes and lessons learned.
Participate in weekly routine cleanings of production room and support areas as needed.
GMP Production Run Readiness (30%)Working with the Downstream supervisor/manager, draft process procedures for assigned projects including:
Batch Records
Material Ordering Checklists (MOCs) and Bill of Materials (BOMs)
SOPs
Chromatography methods
Risk Assessments (RAs)
Job Hazard Analysis (JHAs)
Waste streams
Requests for raw materials, in-house made buffers and tubing assemblies.
Ensure that documents are accurate and reflect the process to be performed.
Communicate effectively and escalate assigned project issues or delays.
Source cGMP compatible equipment for assigned projects
Participate in internal and external (client facing) core team meetings with project leads from other departments.
Process Transfer and Development (15%)With the assistance of the Downstream Manufacturing Supervisor/Manager develop and/or optimize for downstream processes for manufacturing facility fit.
Lead the technical transfer of processes from Process Development laboratories to manufacturing.
Work closely with Process Development leads and participate hands-on with development runs prior to GMP runs
Other duties as assigned (10%)Cross train and perform hands-on activities in Upstream processes as required.
Participate in Practical Process Improvements (PPI) including Kaizens and continuous improvement projects.
How will you get here?Education:Bachelor’s Degree or higher in chemical engineering, biochemistry, biology, or a related field.
Experience:2 years of experience in in a cGMP production and testing environment.
Knowledge, Skills, Abilities:An in-depth understanding of downstream processing methods (Chromatography, TFF, Nanofiltration, Ultracentrifugation, detergent treatment, sterilizing grade filtration).
Working knowledge of cGMP, large scale separation and purification techniques.
Effectively lead and train operators in the techniques described above.
Outstanding planning, organization, multitasking, and communication skills.
Excellent communication skills including technical writing.
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.comThermo 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.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.
Vacancy caducado!